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Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients (HPMADOP)

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ClinicalTrials.gov Identifier: NCT02105740
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
University of Brasilia
Information provided by (Responsible Party):
Gil Montenegro, University of Brasilia

Brief Summary:
The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients, to reduce the level of pain, anxiety and depression. The comparison was made through the scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale (HADS).

Condition or disease Intervention/treatment Phase
Pain Depression Anxiety Disorder Behavioral: Hypnosis Behavioral: Control Not Applicable

Detailed Description:
Volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to hypnosis, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS), will be randomized into two groups of 12 participants each. They might or might not present metastasis, whether or not performed cancer surgery, regardless of the location of the primary tumor, with or without concomitant surgical indication. It will be used the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS) at 3 different times: at baseline, after 7 days and after 2 weeks of the first assessment. It will be done, in the hypnosis group, an hypnosis intervention. It consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression. Then, it will be evaluated the intensity of the pain as well as depression and anxiety in both groups. Finally, the results of both groups will be compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients
Study Start Date : July 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypnosis
Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
Behavioral: Hypnosis
The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.

Active Comparator: Control
Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.
Behavioral: Control
The control and experimental groups respond in 3 different moments to Visual Analogue Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting will be made before the hypnosis. In the second meeting, within an interval of 7 days, the scales will be applied in all patients. Before applying the scales, the hypnosis group will be submitted to the session. The third meeting will occur two weeks later, where the scales will be only applied to compare the groups.




Primary Outcome Measures :
  1. Change of Pain Score in the Visual Analogue Scale [ Time Frame: The study was done with each patient in the first three consecutive weeks after randomization ]
    Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.


Secondary Outcome Measures :
  1. Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: The study was done with each patient in the first three consecutive weeks after randomization ]
    Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of Both sexes
  • Aged 40-70 years susceptible to hypnosis
  • Who have cancer of the digestive tract and pain resulting from this cancer treatment These may or may not have metastasis, have done or not cancer surgery, regardless of the location of the primary tumor or its presence,with or without concomitant surgical indication.This will include patients who have pain scores ≥ 3 in the Visual Analogue Scale (VAS).

Exclusion Criteria:

  • Patient not suggestible to hypnosis
  • Psychotropic drug users,
  • Patients with severe psychiatric disorder, except depression and anxiety

    ,- Patient terminally ill cancer

  • Patients with tumor or cancer metastasis in the central nervous system, _ Deaf and people with mental disabilities and cognitive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105740


Locations
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Brazil
UNB- Universidade de Brasilia
Brasilia, Distrito Federal, Brazil, 70910900
Sponsors and Collaborators
Gil Montenegro
University of Brasilia
Investigators
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Principal Investigator: GIL MONTENEGRO, DOUTORANDO

Publications:
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Responsible Party: Gil Montenegro, PhD student in medical science, University of Brasilia
ClinicalTrials.gov Identifier: NCT02105740     History of Changes
Other Study ID Numbers: UNB19739513900000030
First Posted: April 7, 2014    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gil Montenegro, University of Brasilia:
BEHAVIORAL
HYPNOSIS
ANXIETY
DEPRESSION
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders