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Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01293695
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : September 17, 2015
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gary R. Elkins, Baylor University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hot Flashes
Interventions Behavioral: Hypnosis
Other: Structured attention
Enrollment 187
Recruitment Details Recruitment occurred from December, 2008 to April, 2012. Participants were recruited by using fliers, mailings, billboard advertising and word-of-mouth. Local clinics were also visited and informative materials were left with physicians.
Pre-assignment Details  
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Period Title: Overall Study
Started 93 94
Completed 78 87
Not Completed 15 7
Reason Not Completed
Withdrawal by Subject             7             1
Lost to Follow-up             8             6
Arm/Group Title Hypnosis Structured Attention Total
Hide Arm/Group Description

Receives 5 weeks of hypnotic relaxation therapy (HRT)

Hypnosis: Hypnosis relaxation in five weekly sessions

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Total of all reporting groups
Overall Number of Baseline Participants 93 94 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 187 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
84
  90.3%
87
  92.6%
171
  91.4%
>=65 years
9
   9.7%
7
   7.4%
16
   8.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 187 participants
Female
93
 100.0%
94
 100.0%
187
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 187 participants
American Indian 2 3 5
Asian 1 0 1
African American 20 11 31
Hispanic 6 6 12
White 64 74 138
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants 94 participants 187 participants
93 94 187
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 187 participants
Married 57 65 122
Divorced 8 10 18
Separated 5 5 10
Single 19 12 31
Widowed 4 2 6
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 187 participants
Less than High School 10 6 16
High School Diploma 26 26 52
College, non degree 20 20 40
Associate Degree 12 12 24
Bachelor's Degree 14 22 36
Graduate Degree 11 8 19
Hot Flash Frequency   [1] 
Mean (Standard Deviation)
Unit of measure:  Hot flashes per week
Number Analyzed 93 participants 94 participants 187 participants
75.26  (2.82) 75.21  (3.11) 75.24  (2.97)
[1]
Measure Description: Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their hot flashes over seven days marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).
Hot Flash Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 93 participants 94 participants 187 participants
24.43  (1.02) 22.94  (1.23) 23.69  (1.13)
[1]
Measure Description:

Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).

Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).

The values presented represent the average of daily hot flash scores.

Biolog Hot Flash Monitor (physiological measure)   [1] 
Mean (Standard Deviation)
Unit of measure:  Micro Siemens
Number Analyzed 93 participants 94 participants 187 participants
10.41  (1) 8.85  (.75) 9.63  (.88)
[1]
Measure Description: As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.
Hot Flash Related Daily Interference Scale (HFRDIS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 93 participants 94 participants 187 participants
5.87  (.23) 5.75  (.24) 5.81  (24)
[1]
Measure Description: This questionnaire was used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.
Pittsburg Sleep Quality Index (PSQI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 93 participants 94 participants 187 participants
11.69  (.56) 11.89  (.48) 11.79  (.52)
[1]
Measure Description: The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rated their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score was determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.
1.Primary Outcome
Title Hot Flash Frequency
Hide Description The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).
Time Frame 6 Weeks and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description:

Received 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Overall Number of Participants Analyzed 78 87
Mean (Standard Deviation)
Unit of Measure: hot flashes per week
Week 6 27.19  (2.48) 68.26  (3.10)
Week 12 19.44  (1.96) 62.32  (3.43)
2.Primary Outcome
Title Hot Flash Score
Hide Description

Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).

Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).

The values presented represent the average of daily hot flash scores.

Time Frame 6 Weeks and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description:

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Overall Number of Participants Analyzed 78 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 6 6.71  (.79) 21.03  (1.15)
Week 12 4.61  (.56) 19.41  (1.36)
3.Primary Outcome
Title Hot Flash Related Daily Interference Scale (HFRDIS)
Hide Description This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.
Time Frame 6 Weeks and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description:

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Overall Number of Participants Analyzed 78 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 6 1.85  (.21) 4.71  (.27)
Week 12 1.05  (.20) 4.43  (.28)
4.Secondary Outcome
Title Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture
Hide Description As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.
Time Frame 6 Weeks and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group.
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description:

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions.

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Overall Number of Participants Analyzed 49 70
Mean (Standard Deviation)
Unit of Measure: Micro Siemens
Week 6 6.15  (.81) 9.48  (.87)
Week 12 4.49  (.59) 7.97  (.70)
5.Secondary Outcome
Title Pittsburg Sleep Quality Index (PSQI)
Hide Description The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.
Time Frame 6 Weeks and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description:

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions.

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Overall Number of Participants Analyzed 78 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 6 6.10  (.47) 10.85  (.51)
Week 12 5.42  (.47) 10.66  (.55)
Time Frame Adverse event data were collected for 12 weeks. (i.e.: weekly from baseline to 12 week follow-up)
Adverse Event Reporting Description Adverse events were assessed at each session by participant self-report.
 
Arm/Group Title Hypnosis Structured Attention
Hide Arm/Group Description

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

All-Cause Mortality
Hypnosis Structured Attention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hypnosis Structured Attention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hypnosis Structured Attention
Affected / at Risk (%) Affected / at Risk (%)
Total   13/93 (13.98%)   12/94 (12.77%) 
Skin and subcutaneous tissue disorders     
Skin irritation  [1]  13/93 (13.98%)  12/94 (12.77%) 
Indicates events were collected by systematic assessment
[1]
mild skin irritation from the skin conductance monitor electrode adhesive, requiring no medical intervention to resolve.

limitations: results may not generalize to all women with hot flashes

  • some hot flashes occur at other times than during the climacteric
  • self-selection bias (predispositions to mind-body therapy)
  • population was largely caucasian
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
Name/Title: Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory
Organization: Baylor University
Phone: 254-296-0643
Responsible Party: Gary R. Elkins, Baylor University
ClinicalTrials.gov Identifier: NCT01293695     History of Changes
Other Study ID Numbers: 194610
5U01AT004634 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: January 28, 2015
Results First Posted: September 17, 2015
Last Update Posted: August 16, 2016