Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05407402
Status:
UNKNOWN
Last Update Posted:
2022-06-07
First Post:
2022-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Watching funny videos changes pain', 'timeFrame': '2 month', 'description': 'Visual Pain Scale:\n\nThe pain scores of the patients will be measured after the pre-test and the 4th week using the visual pain scale.'}, {'measure': 'Watching funny videos changes comfort.', 'timeFrame': '2 month', 'description': 'The General Comfort Scale The General Comfort Scale scores of the patients will be measured after the pre-test and the 4th week using the comfort scale.'}], 'primaryOutcomes': [{'measure': 'Laughter yoga changes pain', 'timeFrame': '2 month', 'description': 'Visual Pain Scale:\n\nThe pain scores of the patients will be measured after the pre-test and the 4th week using the visual pain scale.'}, {'measure': 'Laughter yoga changes comfort.', 'timeFrame': '2 month', 'description': 'The General Comfort Scale The General Comfort Scale scores of the patients will be measured after the pre-test and the 4th week using the comfort scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laughter yoga,', 'funny videos,', 'migraine,', 'pain,', 'comfort'], 'conditions': ['Pain, Head']}, 'descriptionModule': {'briefSummary': 'In individuals diagnosed with migraine, laughter yoga will be performed for 45 minutes, 3 times a week for 1 month. the other application group will watch funny videos for 45 minutes, 3 times a week for 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being older than 18 years of age\n* Having been diagnosed with migraine for at least one year\n* Having no mental disability\n\nExclusion Criteria:\n\n* individuals using pain relievers\n* individuals who have done laughter yoga before'}, 'identificationModule': {'nctId': 'NCT05407402', 'briefTitle': 'Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Osmaniye Korkut Ata University'}, 'officialTitle': 'Examination of the Effect of Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine', 'orgStudyIdInfo': {'id': 'Korkut Ata Unıversity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laughter yoga', 'description': 'laughter yoga', 'interventionNames': ['Behavioral: laughter yoga practice']}, {'type': 'EXPERIMENTAL', 'label': 'funny videos,', 'description': 'funny videos,', 'interventionNames': ['Behavioral: watching funny videos']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'control group. routine nursing care will be applied.'}], 'interventions': [{'name': 'laughter yoga practice', 'type': 'BEHAVIORAL', 'description': 'To reduce the pain and increase the comfort of individuals diagnosed with migraine with these planned interventions.', 'armGroupLabels': ['laughter yoga']}, {'name': 'watching funny videos', 'type': 'BEHAVIORAL', 'description': 'To reduce the pain and increase the comfort of individuals diagnosed with migraine with these planned interventions.', 'armGroupLabels': ['funny videos,']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aksaray', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray University', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'may be published at the discretion of the authors, provided appropriate justifications are provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osmaniye Korkut Ata University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Kevser Sevgi Ünal Aslan', 'investigatorAffiliation': 'Osmaniye Korkut Ata University'}}}}