Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04731402
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2021-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Acupressure, Laughter Yoga and Mindfulness on Menopausal Symptoms and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}, {'id': 'D027641', 'term': 'Laughter Therapy'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopause symptoms', 'timeFrame': 'Up to 12 weeks', 'description': 'Menopause Rating Scale is an 11 item scale.The five-point Likert type scale has three sub-dimensions.The higher the scores of each item, the higher the complaints, the higher the total score of the scale, the higher the menopausal complaints.'}, {'measure': 'Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopausal quality of life', 'timeFrame': 'Up to 12 weeks', 'description': 'Menopausal Quality of Life Scale is a Likert-type scale with 29 questions and consists of four domains: vasomotor, psychosocial, physical and sexual. Each question score is from 0 to 6. The increase in the scale score indicates that the severity of the complaints increased.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopausal Symptoms', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the effect of acupressure, laughter yoga and Mindfulness stress reduction program on menopausal symptoms and quality of life.Menopausal period, which is one of the life stages, causes physiological changes and can decrease the quality of life.\n\nThe research is a randomized controlled trial. 180 women who meet the conditions for research will be included in the study. Three instruments were used to obtain the research data: Personal Information Form,Menopausal Symptoms Rating Scale and Menopause-Specific Quality of Life Scale.', 'detailedDescription': "On average, one third of a woman's life passes during menopause. The menopausal period is an important period that brings many physical and psychological changes with it and significantly affects the disease process and the family and society. Cultural and ethnic characteristics of the society are among the important factors that affect women's attitudes towards menopause and the meaning of middle age for women.women seek ways to deal with menopausal symptoms.\n\nwomen prefer drug-free coping methods. Mindfulness stress reduction program, yoga and laughter yoga are an alternative way to reduce menopausal symptoms.. These methods can reduce the complaints and increase the quality of life. For this reason, the effect should be determined in the menopausal period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'It is a specific study for menopause', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in the menopausal period\n\nExclusion Criteria:\n\n* presence of psychiatric illness using psychiatric medication'}, 'identificationModule': {'nctId': 'NCT04731402', 'briefTitle': 'The Effect of Acupressure, Laughter Yoga and Mindfulness on Menopausal Symptoms and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'The Effect of Acupressure, Laughter Yoga and Conscious Awareness on Menopausal Symptoms and Quality of Life in Menopausal Women.', 'orgStudyIdInfo': {'id': 'inonu university ethics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupressure', 'description': 'Acupressure group Acupressure application will be applied twice a week, 24 times in total in 12 weeks. Each acupressure point will be massaged for 30 seconds to provide circulation before compression. After the massage, pressures will be applied consecutively for 90 seconds. The session duration for each woman will be 8 minutes in total, with 2 minutes for each point in each attempt.', 'interventionNames': ['Other: Acupressure, laughter yoga and mindfulness stress reduction program']}, {'type': 'EXPERIMENTAL', 'label': 'Laughter Yoga', 'description': 'Laughter Yoga group Laughter yoga sessions begin with gentle warm-up techniques that include stretching and stretching movements, songs, applause, and body movements. Therapy sessions are between 30-45 minutes.8 sessions of laughter yoga will be done once a week.', 'interventionNames': ['Other: Acupressure, laughter yoga and mindfulness stress reduction program']}, {'type': 'EXPERIMENTAL', 'label': 'mindfulness stress reduction program', 'description': 'mindfulness stress reduction program mindfulness stress reduction program consists of 8 weeks. each week is 2.5 hours. each week has a different theme. There is a 6-hour silence day in the 6th week of the program.', 'interventionNames': ['Other: Acupressure, laughter yoga and mindfulness stress reduction program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'INTERVENTION NOT IMPLEMENTED'}], 'interventions': [{'name': 'Acupressure, laughter yoga and mindfulness stress reduction program', 'type': 'OTHER', 'description': 'Initiatives will be applied to the experimental group. only measurement tools will be applied to the control group', 'armGroupLabels': ['Acupressure', 'Laughter Yoga', 'mindfulness stress reduction program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Malatya', 'state': 'Battalgazi', 'country': 'Turkey (Türkiye)', 'facility': 'Hacer', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'phd', 'investigatorFullName': 'Hacer Unver, PhD', 'investigatorAffiliation': 'Inonu University'}}}}