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Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122369
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : February 7, 2013
Last Update Posted : February 28, 2013
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Elvira Lang, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions Breast Cancer
Anxiety
Pain
Interventions Behavioral: Self-hypnotic Relaxation
Behavioral: Empathic Attention
Enrollment 240
Recruitment Details Between February 2002 and March 2004, 240 eligible patients were recruited and randomly assigned to treatments. Four patients (including the only male) withdrew after entering the biopsy suite before starting with the intervention in the Intervention Groups or data collection in the Standard Care Group.
Pre-assignment Details  
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Period Title: Overall Study
Started 76 82 78
Completed 76 82 78
Not Completed 0 0 0
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation Total
Hide Arm/Group Description As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. Total of all reporting groups
Overall Number of Baseline Participants 76 82 78 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 82 participants 78 participants 236 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
69
  90.8%
74
  90.2%
73
  93.6%
216
  91.5%
>=65 years
7
   9.2%
8
   9.8%
5
   6.4%
20
   8.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 82 participants 78 participants 236 participants
49.2  (13.4) 48.0  (13.22) 47.8  (13.7) 48.3  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 82 participants 78 participants 236 participants
Female
76
 100.0%
82
 100.0%
78
 100.0%
236
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 82 participants 78 participants 236 participants
76 82 78 236
1.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.
Time Frame 0 min
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat; patients on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 82 78
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4.5
(2 to 6)
5
(3 to 7)
5
(3 to 6)
2.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 10 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 81 77
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(2 to 6)
4
(2 to 7)
4
(2 to 6)
3.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 20 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 81 75
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(2 to 6)
4
(2 to 7)
3
(2 to 5)
4.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 30 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 70 72 66
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(2 to 6.5)
4.5
(2 to 6)
4
(2 to 6)
5.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 40 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 59 57 52
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(3 to 7)
5
(3 to 6)
4
(1.25 to 6)
6.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 50 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 42 45 39
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
6
(2.75 to 7)
4
(2 to 6)
3
(1 to 5)
7.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 60 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 32 31 26
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(2.25 to 8)
4
(2 to 6)
2.5
(0 to 5.25)
8.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 70 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 23 23 20
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(3 to 8)
3
(2 to 6)
2.5
(0 to 4)
9.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 80 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 15 12 8
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(2 to 8)
4
(2 to 6)
3
(0 to 4.75)
10.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 90 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 8 7 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(0.5 to 8.75)
7
(1 to 8)
0.5
(0 to 4)
11.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 100 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 7 5 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(0 to 9)
3
(0 to 5.5)
2
(0 to 5)
12.Primary Outcome
Title Anxiety Ratings at Specified Time Point During the Procedure
Hide Description Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame 110 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 4 2 1
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4.5
(0.5 to 8.5)
2
(0 to 3)
5
(5 to 5)
13.Primary Outcome
Title Time Trends of Anxiety Experience
Hide Description Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.
Time Frame 0-110 min
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat; patients undergoing breast biopsy
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 82 78
Measure Type: Number
Unit of Measure: logit slopes
0.18 -0.04 -0.27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Empathic Attention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Empathic Attention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Empathic Attention, Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
14.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 0 min
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 82 78
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 1.75)
0
(0 to 0)
0
(0 to 1)
15.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 10 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 81 77
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 2)
0
(0 to 1)
0
(0 to 2)
16.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 20 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 81 75
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(0 to 4)
0
(0 to 2)
0
(0 to 2)
17.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 30 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 70 72 65
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 4)
0
(0 to 3)
0
(0 to 2)
18.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 40 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 59 57 52
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 5)
2
(0 to 4)
0
(0 to 3)
19.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 50 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 41 45 39
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(0 to 6)
2
(0 to 4.5)
1
(0 to 3)
20.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 60 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 32 31 26
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2.5
(0 to 4)
2
(0 to 5)
1
(0 to 6)
21.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 70 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 23 23 20
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(2 to 6)
2
(0 to 4)
2
(0 to 4.5)
22.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 80 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 15 12 8
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(2 to 7)
3.5
(1.25 to 4.75)
2.5
(0 to 7)
23.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 90 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 8 7 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(5 to 8)
2
(1 to 5)
1.5
(0 to 7.5)
24.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 100 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 7 5 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
9
(7 to 9)
2
(1 to 4.5)
2
(0.5 to 5.5)
25.Primary Outcome
Title Pain Ratings at Specified Time Point During the Procedure
Hide Description Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame 110 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients remaining on procedure table
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 4 2 1
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
8.5
(8 to 9.75)
3
(3 to 3)
10
(10 to 10)
26.Primary Outcome
Title Time Trends of Pain Experience
Hide Description Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.
Time Frame 0-110 min
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat; patients undergoing breast biopsy
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 76 82 78
Measure Type: Number
Unit of Measure: logit slopes
0.53 0.37 0.34
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Empathic Attention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Ordinal regression
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Empathic Attention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Empathic Attention, Self-Hypnotic Relaxation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Proportional odds model
Comments [Not Specified]
27.Secondary Outcome
Title Salivary Cortisol Secretion
Hide Description Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.
Time Frame Patients were followed for the 5 days following their breast biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the "known malignant" group, 37 in the "known benign" group, and 73 in the "uncertain group" totaling 126 patients.
Arm/Group Title Known Benign Disease Known Malignant Disease Uncertain Diagnosis
Hide Arm/Group Description:
Women who were diagnosed to have benign disease
Women who were diagnosed to have malignant disease
were in the "uncertain" diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1).
Overall Number of Participants Analyzed 37 16 73
Mean (95% Confidence Interval)
Unit of Measure: ln (microgram/dL)/hr
-0.154
(-0.197 to -0.111)
-0.110
(-0.147 to -0.073)
-0.092
(-0.113 to -0.072)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Known Benign Disease, Uncertain Diagnosis
Comments The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments Bonferoni correction was made so that results with p<0.0167 are considered significant
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Known Malignant Disease, Uncertain Diagnosis
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments Bonferoni correction was made so that results with p<0.0167 are considered significant.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Known Benign Disease, Known Malignant Disease
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments Bonferoni correction was made so that results with p<0.0167 are considered significant.
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title Impact of Event Scale (IES-15)
Hide Description

The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.

≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy

Time Frame Patients were followed for up to 3 weeks after their biopsy until the time of their surgery
Hide Outcome Measure Data
Hide Analysis Population Description
These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description:
As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Overall Number of Participants Analyzed 7 4 8
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
25  (10.7) 27  (13.7) 24  (15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Empathic Attention, Self-Hypnotic Relaxation
Comments The null-hypothesis was that there would be no difference among groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Patients were followed for up to one week after their biopsy
Adverse Event Reporting Description Adverse event reporting was done using the Reporting Standard of the Society of Interventional Radiology
 
Arm/Group Title Standard of Care Empathic Attention Self-Hypnotic Relaxation
Hide Arm/Group Description As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
All-Cause Mortality
Standard of Care Empathic Attention Self-Hypnotic Relaxation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Standard of Care Empathic Attention Self-Hypnotic Relaxation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/82 (0.00%)      0/78 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Standard of Care Empathic Attention Self-Hypnotic Relaxation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/76 (9.21%)      11/82 (13.41%)      3/78 (3.85%)    
Surgical and medical procedures       
Hematoma  1  5/76 (6.58%)  5 9/82 (10.98%)  9 3/78 (3.85%)  3
Vasovagal episode  1  1/76 (1.32%)  1 2/82 (2.44%)  2 0/78 (0.00%)  0
Vomiting  1  1/76 (1.32%)  1 0/82 (0.00%)  0 0/78 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SIR Standard
For the assessment of the Secondary Outcome parameter we were able to recruit only 19 women whom we could contact early enough on the day of their breast cancer surgery to fill out the IES. This limits the power of the statistical analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elvira V. Lang, MD
Organization: Beth Israel Deaconess Medical Center (at time of study); now Hypnalgesics, LLC
Phone: 978 404 9724
EMail: elang@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Elvira Lang, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00122369    
Other Study ID Numbers: DAMD 17-01-1-0153
2001P-001681
First Submitted: July 20, 2005
First Posted: July 22, 2005
Results First Submitted: February 3, 2012
Results First Posted: February 7, 2013
Last Update Posted: February 28, 2013