Trial Outcomes & Findings for A Mind-Body Intervention for Hot Flash Management (NCT NCT03572153)
NCT ID: NCT03572153
Last Updated: 2025-06-05
Results Overview
Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: * mild = 1 * moderate = 2 * severe = 3 * very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
COMPLETED
NA
250 participants
The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
2025-06-05
Participant Flow
Participant milestones
| Measure |
Self-Administered Hypnosis
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
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Self-Administered White Noise Hypnosis
Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered White Noise Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Overall Study
STARTED
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126
|
124
|
|
Overall Study
COMPLETED
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107
|
97
|
|
Overall Study
NOT COMPLETED
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19
|
27
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Mind-Body Intervention for Hot Flash Management
Baseline characteristics by cohort
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered White Noise Sham Hypnosis
n=124 Participants
Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered White Noise Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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Total
n=250 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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55.69 years
STANDARD_DEVIATION 6.67 • n=5 Participants
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56.17 years
STANDARD_DEVIATION 7.17 • n=7 Participants
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55.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
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Sex: Female, Male
Female
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126 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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126 participants
n=5 Participants
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124 participants
n=7 Participants
|
250 participants
n=5 Participants
|
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Breast Cancer Survivor
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33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: * mild = 1 * moderate = 2 * severe = 3 * very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Hot Flash Daily Diary
Baseline (Week 0)
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88.7 Hot Flash Score
Standard Deviation 61.3
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94.6 Hot Flash Score
Standard Deviation 81.6
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Hot Flash Daily Diary
Endpoint (Week 6)
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41.3 Hot Flash Score
Standard Deviation 50.8
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55.9 Hot Flash Score
Standard Deviation 50.9
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Hot Flash Daily Diary
Follow-up (Week 12)
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34.7 Hot Flash Score
Standard Deviation 34.4
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52.8 Hot Flash Score
Standard Deviation 49.4
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SECONDARY outcome
Timeframe: The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Hot Flash Related Daily Interference Scale
Baseline
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49.3 score on a scale
Standard Deviation 22.6
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47.3 score on a scale
Standard Deviation 22.4
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Hot Flash Related Daily Interference Scale
Endpoint
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25 score on a scale
Standard Deviation 22.4
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29.6 score on a scale
Standard Deviation 22
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Hot Flash Related Daily Interference Scale
Follow-up
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21.4 score on a scale
Standard Deviation 20.2
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24.2 score on a scale
Standard Deviation 20.3
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SECONDARY outcome
Timeframe: Baseline, 6 & 12 WeeksThis 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Emotional Distress Anxiety Scale
Baseline
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49.83 units on a scale
Standard Deviation 16.19
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50.82 units on a scale
Standard Deviation 16.98
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Emotional Distress Anxiety Scale
Endpoint
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45.93 units on a scale
Standard Deviation 15.05
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47.59 units on a scale
Standard Deviation 16.74
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Emotional Distress Anxiety Scale
Follow-up
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44.85 units on a scale
Standard Deviation 16.60
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47.79 units on a scale
Standard Deviation 16.77
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SECONDARY outcome
Timeframe: Baseline, 6, & 12 weeks.This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Pittsburgh Sleep Quality Index
Baseline
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7.08 units on a scale
Standard Deviation 2.23
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7.13 units on a scale
Standard Deviation 2.51
|
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Pittsburgh Sleep Quality Index
Endpoint
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6.23 units on a scale
Standard Deviation 2.53
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6.31 units on a scale
Standard Deviation 2.39
|
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Pittsburgh Sleep Quality Index
Follow-up
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6.33 units on a scale
Standard Deviation 2.31
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6.10 units on a scale
Standard Deviation 2.15
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SECONDARY outcome
Timeframe: The Subject Global Impressions of Change will be completed only at 6 weeks.Participants were asked to fill out the Subject Global Impressions of Change at endpoint (week 6) to gauge participants' perceived benefit. The Subject Global Impression of Change is a single item in which the participant rates, from 0 to 4, the change in hot flashes since beginning the study. Response options range from "not at all" (0), "a little" (1), "somewhat" (2), "quite a bit" (3), "totally satisfied" (4). The question used was, "How satisfied are you with the impact of the study treatment on your hot flashes?". This question has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials prior to this study.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Subject Global Impression of Change
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1.92 Units on a Scale
Standard Deviation 1.066
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1.20 Units on a Scale
Standard Deviation 1.228
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SECONDARY outcome
Timeframe: Baseline, 6, & 12 weeksThis is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Perceived Stress Scale
Baseline
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12.38 units on a scale
Standard Deviation 6.686
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12.11 units on a scale
Standard Deviation 6.647
|
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Perceived Stress Scale
Week 6
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11.36 units on a scale
Standard Deviation 6.368
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11.16 units on a scale
Standard Deviation 6.874
|
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Perceived Stress Scale
Week 12
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10.26 units on a scale
Standard Deviation 6.123
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10.64 units on a scale
Standard Deviation 6.935
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OTHER_PRE_SPECIFIED outcome
Timeframe: The practice log was completed daily by the participants and submitted to the interventionists at the end of each week throughout the study's duration (weeks one through six) and at follow-up (week 12)."Participants in both groups were given the Self-Hypnosis Practice Log to record daily practice of self-hypnosis or sham hypnosis throughout the 6-week intervention period and at the week 12 follow-up as a measure of intervention adherence. Adherence scores (number of practices per week) were calculated as the total frequency of reported practices according to group assignment in a seven-day period with or without the aid of an audio recording. Average adherence was calculated by averaging the adherence scores of week 1(initiation of study), week 6 (end of intervention), and week 12 (follow-up).
Outcome measures
| Measure |
Self-Administered Hypnosis
n=126 Participants
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered Hypnosis: Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
|
Self-Administered Sham Hypnosis
n=124 Participants
Self-administered sham hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Self-Administered Sham Hypnosis: Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
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|---|---|---|
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Self-Hypnosis Practice Log
Baseline
|
7.4 Number of practices per week
Standard Deviation 4.4
|
7.6 Number of practices per week
Standard Deviation 3.4
|
|
Self-Hypnosis Practice Log
Endpoint
|
10.9 Number of practices per week
Standard Deviation 6.6
|
7.4 Number of practices per week
Standard Deviation 3.1
|
|
Self-Hypnosis Practice Log
Follow-up
|
8.3 Number of practices per week
Standard Deviation 7.2
|
5.6 Number of practices per week
Standard Deviation 5.1
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Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=126 participants at risk
Self-Administered Hypnosis
|
Control
n=124 participants at risk
Self-Administered Sham Hypnosis
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|---|---|---|
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General disorders
Mild/Moderate Adverse Events
|
3.2%
4/126 • Number of events 7 • All participants were monitored for Adverse Events during the entire study duration, an average of 3 months.
Any serious adverse events were reported to the IRB and NCCIH.
|
4.0%
5/124 • Number of events 8 • All participants were monitored for Adverse Events during the entire study duration, an average of 3 months.
Any serious adverse events were reported to the IRB and NCCIH.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place