Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01293695
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2011-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gary_elkins@baylor.edu', 'phone': '254-296-0643', 'title': 'Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory', 'organization': 'Baylor University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'limitations: results may not generalize to all women with hot flashes\n\n* some hot flashes occur at other times than during the climacteric\n* self-selection bias (predispositions to mind-body therapy)\n* population was largely caucasian'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 12 weeks. (i.e.: weekly from baseline to 12 week follow-up)', 'description': 'Adverse events were assessed at each session by participant self-report.', 'eventGroups': [{'id': 'EG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions', 'otherNumAtRisk': 93, 'otherNumAffected': 13, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis', 'otherNumAtRisk': 94, 'otherNumAffected': 12, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'notes': 'mild skin irritation from the skin conductance monitor electrode adhesive, requiring no medical intervention to resolve.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hot Flash Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnosis', 'description': 'Received 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.'}, {'id': 'OG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '27.19', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '68.26', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '19.44', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '62.32', 'spread': '3.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 12 Weeks', '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).', 'unitOfMeasure': 'hot flashes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hot Flash Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged.'}, {'id': 'OG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '6.71', 'spread': '.79', 'groupId': 'OG000'}, {'value': '21.03', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.61', 'spread': '.56', 'groupId': 'OG000'}, {'value': '19.41', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 12 Weeks', '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).\n\nHot 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).\n\nThe values presented represent the average of daily hot flash scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions.'}, {'id': 'OG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '6.15', 'spread': '.81', 'groupId': 'OG000'}, {'value': '9.48', 'spread': '.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.49', 'spread': '.59', 'groupId': 'OG000'}, {'value': '7.97', 'spread': '.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 12 Weeks', '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.', 'unitOfMeasure': 'Micro Siemens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Pittsburg Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions.'}, {'id': 'OG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '6.10', 'spread': '.47', 'groupId': 'OG000'}, {'value': '10.85', 'spread': '.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.42', 'spread': '.47', 'groupId': 'OG000'}, {'value': '10.66', 'spread': '.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 12 Weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions'}, {'id': 'OG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.85', 'spread': '.21', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.05', 'spread': '.20', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 12 Weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy\n\nHypnosis: Hypnosis relaxation in five weekly sessions'}, {'id': 'FG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy (HRT)\n\nHypnosis: Hypnosis relaxation in five weekly sessions'}, {'id': 'BG001', 'title': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy\n\nStructured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Divorced', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Separated', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Single', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'Less than High School', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'High School Diploma', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'College, non degree', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Associate Degree', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': "Bachelor's Degree", 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Graduate Degree', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hot Flash Frequency', 'classes': [{'categories': [{'measurements': [{'value': '75.26', 'spread': '2.82', 'groupId': 'BG000'}, {'value': '75.21', 'spread': '3.11', 'groupId': 'BG001'}, {'value': '75.24', 'spread': '2.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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).', 'unitOfMeasure': 'hot flashes per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hot Flash Score', 'classes': [{'categories': [{'measurements': [{'value': '24.43', 'spread': '1.02', 'groupId': 'BG000'}, {'value': '22.94', 'spread': '1.23', 'groupId': 'BG001'}, {'value': '23.69', 'spread': '1.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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).\n\nHot 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).\n\nThe values presented represent the average of daily hot flash scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biolog Hot Flash Monitor (physiological measure)', 'classes': [{'categories': [{'measurements': [{'value': '10.41', 'spread': '1', 'groupId': 'BG000'}, {'value': '8.85', 'spread': '.75', 'groupId': 'BG001'}, {'value': '9.63', 'spread': '.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'micro Siemens', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'classes': [{'categories': [{'measurements': [{'value': '5.87', 'spread': '.23', 'groupId': 'BG000'}, {'value': '5.75', 'spread': '.24', 'groupId': 'BG001'}, {'value': '5.81', 'spread': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburg Sleep Quality Index (PSQI)', 'classes': [{'categories': [{'measurements': [{'value': '11.69', 'spread': '.56', 'groupId': 'BG000'}, {'value': '11.89', 'spread': '.48', 'groupId': 'BG001'}, {'value': '11.79', 'spread': '.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2011-02-10', 'resultsFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-18', 'studyFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot Flash Frequency', 'timeFrame': '6 Weeks and 12 Weeks', '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).'}, {'measure': 'Hot Flash Score', 'timeFrame': '6 Weeks and 12 Weeks', '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).\n\nHot 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).\n\nThe values presented represent the average of daily hot flash scores.'}, {'measure': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': '6 Weeks and 12 Weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture', 'timeFrame': '6 Weeks and 12 Weeks', '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.'}, {'measure': 'Pittsburg Sleep Quality Index (PSQI)', 'timeFrame': '6 Weeks and 12 Weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hot flashes', 'post menopausal women', 'skin conductance monitors', 'hypnosis', 'hypnotizability'], 'conditions': ['Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '34403019', 'type': 'DERIVED', 'citation': 'Roberts RL, Rhodes JR, Elkins GR. Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause. J Clin Psychol Med Settings. 2021 Dec;28(4):868-881. doi: 10.1007/s10880-021-09810-3. Epub 2021 Aug 17.'}, {'pmid': '21989181', 'type': 'DERIVED', 'citation': 'Elkins GR, Fisher WI, Johnson AK. Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial. BMC Complement Altern Med. 2011 Oct 11;11:92. doi: 10.1186/1472-6882-11-92.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. It is felt that the Hypnosis Intervention will result in significantly lower hot flash frequency, severity and daily interference scores (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.', 'detailedDescription': "The aging population of the United States and findings from the Women's Health Initiative that indicate a shift in the risk/benefits balance of hormone therapy have created a growing interest in alternative treatments for hot flashes. Hot flashes are among the most severe and frequent symptoms experienced by women during menopause. Over 66% of post-menopausal women experience hot flashes. As a result, there is a pressing need for safe and effective treatments for hot flashes. Hypnosis is one mind-body therapy that seems particularly promising for treating hot flashes.\n\nHowever, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with post-menopausal women has yet to be established relative to a Structured-Attention Control. This is a critical step to further investigate the intervention and to determine if hypnosis reduces the symptoms (i.e. the number of physiological hot flashes) or only the women's perception of symptoms.\n\nAlso, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is not known. The present study will compare hypnosis to a Structured-Attention Control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial.\n\nInnovations of this study are that it will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal as defined by:\n\n 1. no menstrual period in the past 12 months;\n 2. no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or\n 3. women who have had a bilateral oophorectomy.\n* A self-reported history of a minimum of 7 hot flashes per day or 50 hot flashes per week at baseline.\n* Age over 18 years and ability to give her own consent for participation in the study.\n* Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment\n* Ability to attend weekly sessions.\n\nExclusion Criteria:\n\n* Receiving other simultaneous treatment for hot flashes.\n* Using any CAM (Complementary and Alternative Medicine) treatments for vasomotor symptoms • Any medical or psychiatric condition that in the opinion of the investigator puts the participant at potential risk during the study.\n* Currently using hypnosis for any reason.\n* Inability to speak or understand English'}, 'identificationModule': {'nctId': 'NCT01293695', 'briefTitle': 'Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Baylor University'}, 'officialTitle': 'Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '194610'}, 'secondaryIdInfos': [{'id': '5U01AT004634', 'link': 'https://reporter.nih.gov/quickSearch/5U01AT004634', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypnosis', 'description': 'Receives 5 weeks of hypnotic relaxation therapy', 'interventionNames': ['Behavioral: Hypnosis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Structured Attention', 'description': 'Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy', 'interventionNames': ['Other: Structured attention']}], 'interventions': [{'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'otherNames': ['Hypnotic relaxation therapy', 'Hypnosis relaxation', 'Hypnotic intervention', 'Hypnosis intervention'], 'description': 'Hypnosis relaxation in five weekly sessions', 'armGroupLabels': ['Hypnosis']}, {'name': 'Structured attention', 'type': 'OTHER', 'otherNames': ['Placebo Comparator'], 'description': 'Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy', 'armGroupLabels': ['Structured Attention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76798', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Mind-Body Medicine Research Lab-Baylor University', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Gary R Elkins, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gary R. Elkins', 'investigatorAffiliation': 'Baylor University'}}}}