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Trial record 55 of 238 for:    essential oil

Lavender Aromatherapy for Anxiety During Urodynamics

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ClinicalTrials.gov Identifier: NCT02344745
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Begum Ozel, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Conditions Anxiety
Pain
Interventions Other: Lavandula angustifolia essential oil (Aura Cacia)
Other: Distilled water
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Lavender
Hide Arm/Group Description

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Period Title: Overall Study
Started 40 40
Completed 38 40
Not Completed 2 0
Reason Not Completed
Data collection sheets were lost             2             0
Arm/Group Title Control Lavender Total
Hide Arm/Group Description

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 78 participants
48.0  (7.5) 49.0  (8.0) 48.5  (7.9)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
38
 100.0%
40
 100.0%
78
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Hispanic or Latino
37
  97.4%
39
  97.5%
76
  97.4%
Not Hispanic or Latino
1
   2.6%
1
   2.5%
2
   2.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Anxiety   [1] 
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 38 participants 40 participants 78 participants
4
(1 to 9)
5
(1 to 10)
5
(1 to 10)
[1]
Measure Description: Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Since all participants had baseline anxiety, the lowest score recorded was 1. Higher values indicate more anxiety.
Pain   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 40 participants 78 participants
0
(0 to 5)
0
(0 to 4)
0
(0 to 5)
[1]
Measure Description: Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
1.Primary Outcome
Title Anxiety Measured by VAS
Hide Description Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.
Time Frame At the time of catheter placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lavender
Hide Arm/Group Description:

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Overall Number of Participants Analyzed 38 40
Median (Full Range)
Unit of Measure: cm
4
(0 to 9)
3
(0 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lavender
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Wong Baker Pain Scale
Hide Description Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Time Frame At the time of catheter placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lavender
Hide Arm/Group Description:

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Overall Number of Participants Analyzed 38 40
Median (Full Range)
Unit of Measure: units on a scale
0
(0 to 5)
0
(0 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lavender
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Anxiety Measured by VAS
Hide Description Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.
Time Frame 15 min after removal of the urodynamics catheters
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lavender
Hide Arm/Group Description:

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Overall Number of Participants Analyzed 38 39
Median (Full Range)
Unit of Measure: cm
0.5
(0 to 5)
0
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lavender
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 Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Wong Baker Pain Scale
Hide Description Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Time Frame 15 min after removal of the urodynamics catheters
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lavender
Hide Arm/Group Description:

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Overall Number of Participants Analyzed 38 39
Median (Full Range)
Unit of Measure: units on a scale
0
(0 to 5)
0
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lavender
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame The participants were observed for 60 minutes after administration of aromatherapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Lavender
Hide Arm/Group Description

Distilled water

Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavandula angustifolia essential oil (Aura Cacia)

Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

All-Cause Mortality
Control Lavender
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Lavender
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Lavender
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
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: Begum Ozel, M.D.
Organization: Keck School of Medicine
Phone: 323-226-3416
EMail: ozel@usc.edu
Publications:
Layout table for additonal information
Responsible Party: Begum Ozel, University of Southern California
ClinicalTrials.gov Identifier: NCT02344745     History of Changes
Other Study ID Numbers: HS-14-00444
First Submitted: January 7, 2015
First Posted: January 26, 2015
Results First Submitted: June 1, 2016
Results First Posted: December 16, 2016
Last Update Posted: December 16, 2016