Trial Outcomes & Findings for Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial (NCT NCT01293695)

NCT ID: NCT01293695

Last Updated: 2016-08-16

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 187 participants
• Primary outcome timeframe: 6 Weeks and 12 Weeks
• Results posted on: 2016-08-16

Participant Flow

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.

Participant milestones

Measure	Hypnosis Receives 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions	Structured Attention 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 Study STARTED	93	94
Overall Study COMPLETED	78	87
Overall Study NOT COMPLETED	15	7

Reasons for withdrawal

Measure	Hypnosis Receives 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions	Structured Attention 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 Study Withdrawal by Subject	7	1
Overall Study Lost to Follow-up	8	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Hypnosis n=93 Participants Receives 5 weeks of hypnotic relaxation therapy (HRT) Hypnosis: Hypnosis relaxation in five weekly sessions	Structured Attention n=94 Participants 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 n=187 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants	87 Participants n=7 Participants	171 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	94 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized African American	20 participants n=5 Participants	11 participants n=7 Participants	31 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized White	64 participants n=5 Participants	74 participants n=7 Participants	138 participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	94 participants n=7 Participants	187 participants n=5 Participants
Marital Status Married	57 participants n=5 Participants	65 participants n=7 Participants	122 participants n=5 Participants
Marital Status Divorced	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Marital Status Separated	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Marital Status Single	19 participants n=5 Participants	12 participants n=7 Participants	31 participants n=5 Participants
Marital Status Widowed	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Education Less than High School	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Education High School Diploma	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants
Education College, non degree	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Education Associate Degree	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Education Bachelor's Degree	14 participants n=5 Participants	22 participants n=7 Participants	36 participants n=5 Participants
Education Graduate Degree	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Hot Flash Frequency	75.26 hot flashes per week STANDARD_DEVIATION 2.82 • n=5 Participants	75.21 hot flashes per week STANDARD_DEVIATION 3.11 • n=7 Participants	75.24 hot flashes per week STANDARD_DEVIATION 2.97 • n=5 Participants
Hot Flash Score	24.43 units on a scale STANDARD_DEVIATION 1.02 • n=5 Participants	22.94 units on a scale STANDARD_DEVIATION 1.23 • n=7 Participants	23.69 units on a scale STANDARD_DEVIATION 1.13 • n=5 Participants
Biolog Hot Flash Monitor (physiological measure)	10.41 micro Siemens STANDARD_DEVIATION 1 • n=5 Participants	8.85 micro Siemens STANDARD_DEVIATION .75 • n=7 Participants	9.63 micro Siemens STANDARD_DEVIATION .88 • n=5 Participants
Hot Flash Related Daily Interference Scale (HFRDIS)	5.87 units on a scale STANDARD_DEVIATION .23 • n=5 Participants	5.75 units on a scale STANDARD_DEVIATION .24 • n=7 Participants	5.81 units on a scale STANDARD_DEVIATION 24 • n=5 Participants
Pittsburg Sleep Quality Index (PSQI)	11.69 units on a scale STANDARD_DEVIATION .56 • n=5 Participants	11.89 units on a scale STANDARD_DEVIATION .48 • n=7 Participants	11.79 units on a scale STANDARD_DEVIATION .52 • n=5 Participants

PRIMARY outcome

Timeframe: 6 Weeks and 12 Weeks

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).

Outcome measures

Measure	Hypnosis n=78 Participants Received 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.	Structured Attention n=87 Participants 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
Hot Flash Frequency Week 6	27.19 hot flashes per week Standard Deviation 2.48	68.26 hot flashes per week Standard Deviation 3.10
Hot Flash Frequency Week 12	19.44 hot flashes per week Standard Deviation 1.96	62.32 hot flashes per week Standard Deviation 3.43

PRIMARY outcome

Timeframe: 6 Weeks and 12 Weeks

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.

Outcome measures

Measure	Hypnosis n=78 Participants Received 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.	Structured Attention n=87 Participants 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
Hot Flash Score Week 6	6.71 units on a scale Standard Deviation .79	21.03 units on a scale Standard Deviation 1.15
Hot Flash Score Week 12	4.61 units on a scale Standard Deviation .56	19.41 units on a scale Standard Deviation 1.36

PRIMARY outcome

Timeframe: 6 Weeks and 12 Weeks

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.

Outcome measures

Measure	Hypnosis n=78 Participants Received 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.	Structured Attention n=87 Participants 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
Hot Flash Related Daily Interference Scale (HFRDIS) Week 6	1.85 units on a scale Standard Deviation .21	4.71 units on a scale Standard Deviation .27
Hot Flash Related Daily Interference Scale (HFRDIS) Week 12	1.05 units on a scale Standard Deviation .20	4.43 units on a scale Standard Deviation .28

SECONDARY outcome

Timeframe: 6 Weeks and 12 Weeks

Population: 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.

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.

Outcome measures

Measure	Hypnosis n=49 Participants Received 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.	Structured Attention n=70 Participants 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
Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture Week 6	6.15 Micro Siemens Standard Deviation .81	9.48 Micro Siemens Standard Deviation .87
Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture Week 12	4.49 Micro Siemens Standard Deviation .59	7.97 Micro Siemens Standard Deviation .70

SECONDARY outcome

Timeframe: 6 Weeks and 12 Weeks

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.

Outcome measures

Measure	Hypnosis n=78 Participants Received 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.	Structured Attention n=87 Participants 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
Pittsburg Sleep Quality Index (PSQI) Week 6	6.10 units on a scale Standard Deviation .47	10.85 units on a scale Standard Deviation .51
Pittsburg Sleep Quality Index (PSQI) Week 12	5.42 units on a scale Standard Deviation .47	10.66 units on a scale Standard Deviation .55

Adverse Events

Hypnosis

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Structured Attention

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hypnosis n=93 participants at risk Receives 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions	Structured Attention n=94 participants at risk 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
Skin and subcutaneous tissue disorders Skin irritation	14.0% 13/93 • Adverse event data were collected for 12 weeks. (i.e.: weekly from baseline to 12 week follow-up) Adverse events were assessed at each session by participant self-report.	12.8% 12/94 • Adverse event data were collected for 12 weeks. (i.e.: weekly from baseline to 12 week follow-up) Adverse events were assessed at each session by participant self-report.

Additional Information

Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory

Baylor University

Phone: 254-296-0643

Email: gary_elkins@baylor.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place