Trial · NCT00711529
Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
NCT00711529, Phase 3, Completed, Women and Infants Hospital of Rhode Island; results first posted 2013-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes. Trials, record NCT00711529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00711529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
- NCT number
- NCT00711529
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Conditions
- Breast Cancer, Hot Flashes
- Interventions
- Hypnotherapy, gabapentin
- First posted
- 2008-07-09
- Last updated
- 2013-06-24
- Results first posted
- 2013-06-24
- Limitations and caveats
We were unable to meet recruitment goals because of 1) lower-than-anticipated rate of referrals, and 2) subjects' unwillingness to randomization. This resulted in small numbers that limit interpretation of results.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Daily Hot Flashes | Baseline | Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries. |
| Primary | Number of Daily Hot Flashes | Week 4 | Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark. |
| Primary | Number of Daily Hot Flashes | Week 8 | Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark. |
| Primary | Hot Flash Severity Score | Baseline | The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. |
| Primary | Hot Flash Severity Score | Week 4 | The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. |
| Primary | Hot Flash Severity Score | Week 8 | The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. |
| Secondary | Hot Flash Related Daily Interference Score (HFRDIS) | Baseline | The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization). |
| Secondary | Hot Flash Related Daily Interference Score (HFRDIS) | Week 4 | The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point. |
| Secondary | Hot Flash Related Daily Interference Score (HFRDIS) | Week 8 | The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Daily Hot Flashes | Baseline | daily hot flashes | MEDIAN | |
| PRIMARY | Number of Daily Hot Flashes | Week 4 | daily hot flashes | MEDIAN | |
| PRIMARY | Number of Daily Hot Flashes | Week 8 | daily hot flashes | MEDIAN | |
| PRIMARY | Hot Flash Severity Score | Baseline | units on a scale (severity score) | MEDIAN | |
| PRIMARY | Hot Flash Severity Score | Week 4 | units on a scale (severity score) | MEDIAN | |
| PRIMARY | Hot Flash Severity Score | Week 8 | units on a scale (severity score) | MEDIAN | |
| SECONDARY | Hot Flash Related Daily Interference Score (HFRDIS) | Baseline | units on a scale (HFRDIS) | MEDIAN | |
| SECONDARY | Hot Flash Related Daily Interference Score (HFRDIS) | Week 4 | units on a scale (HFRDIS) | MEDIAN | |
| SECONDARY | Hot Flash Related Daily Interference Score (HFRDIS) | Week 8 | units on a scale (HFRDIS) | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Daily Hot Flashes | Hypnotherapy | 5 | Full Range 2 to 11 | daily hot flashes | |
| Number of Daily Hot Flashes | Gabapentin | 4.5 | Full Range 2 to 9 | daily hot flashes | |
| Number of Daily Hot Flashes | Hypnotherapy | 4 | Full Range 1 to 7 | daily hot flashes | |
| Number of Daily Hot Flashes | Gabapentin | 4 | Full Range 2 to 9 | daily hot flashes | |
| Number of Daily Hot Flashes | Hypnotherapy | 1 | Full Range 0 to 7 | daily hot flashes | |
| Number of Daily Hot Flashes | Gabapentin | 3 | Full Range 3 to 5.5 | daily hot flashes | |
| Hot Flash Severity Score | Hypnotherapy | 10 | Full Range 2 to 14 | units on a scale (severity score) | |
| Hot Flash Severity Score | Gabapentin | 7.5 | Full Range 2 to 17.5 | units on a scale (severity score) | |
| Hot Flash Severity Score | Hypnotherapy | 6.5 | Full Range 1 to 11 | units on a scale (severity score) | |
| Hot Flash Severity Score | Gabapentin | 4 | Full Range 2 to 17.5 | units on a scale (severity score) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hypnotherapy | 13 | |
| Overall Study | STARTED | Gabapentin | 14 | |
| Overall Study | COMPLETED | Hypnotherapy | 9 | |
| Overall Study | COMPLETED | Gabapentin | 8 | |
| Overall Study | NOT COMPLETED | Hypnotherapy | 4 | |
| Overall Study | NOT COMPLETED | Gabapentin | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hypnotherapy | ||
| Total, all-cause mortality | Gabapentin | ||
| Total, other adverse events | Hypnotherapy | 0 | 13 |
| Total, other adverse events | Gabapentin | 0 | 14 |
| Total, serious adverse events | Hypnotherapy | 0 | 13 |
| Total, serious adverse events | Gabapentin | 0 | 14 |
Source ClinicalTrials.gov
Papers33
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Hypnotherapy vs Gabapentin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00711529
GET https://conductscience.org/api/trials/v1/NCT00711529/papers?page=2