Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 4:48 PM
Study NCT ID:
NCT06965959
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2025-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE EFFECT OF EXERGAMING APPLICATION AND AUTOGENIC RELAXATION TECHNIQUE ON PSYCHOLOGICAL WELL-BEING AND LIFE ENGAGEMENT OF NURSING HOME RESIDENTS: A RANDOMİZED CONTROLLED TRİAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001326', 'term': 'Autogenic Training'}], 'ancestors': [{'id': 'D006990', 'term': 'Hypnosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to one of three parallel groups: (1) exergaming intervention group, (2) autogenic relaxation intervention group, and (3) control group. Each group received their assigned intervention separately, and no crossover occurred between arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Psychological Well-Being Score', 'timeFrame': 'Baseline, Week 4, Week 8, and Week 16 (4 follow-ups total)', 'description': 'Psychological well-being was measured using the Elderly Psychological Well-Being Scale. The scale evaluates emotional, cognitive, and social well-being. Higher scores indicate better psychological well-being.'}, {'measure': 'Change in Life Engagement Score', 'timeFrame': 'Baseline, Week 4, Week 8, and Week 16 (4 follow-ups total)', 'description': 'Life engagement was assessed with the Life Engagement Scale for Older Adults, which measures the degree of purpose, activity, and connectedness perceived by the elderly.'}, {'measure': 'Standardize Mini Mental Test', 'timeFrame': 'Baseline', 'description': 'Cognitive function was evaluated using the Standardized Mini Mental Test (SMMT), which assesses orientation, registration, attention, recall, and language. The test was used to monitor cognitive stability during the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exergaming', 'Autogenic Relaxation', 'Psychological Well-Being', 'Life Engagement', 'Nursing Home Residents'], 'conditions': ['Psychological Well-being', 'Nursing Homes Residents', 'Aging', 'Exergaming', 'Mind-Body Therapies', 'Quality of Life', 'Health Promotion']}, 'descriptionModule': {'briefSummary': 'This interventional clinical trial was conducted to evaluate the effects of Antroyun (exergaming) and autogenic relaxation techniques on psychological well-being and life engagement among older adults living in nursing homes. Participants were randomly assigned to one of three groups: Antroyun intervention group, autogenic relaxation group, and a control group. Interventions were applied twice per week for eight weeks.\n\nThe results indicated that both interventions had a significant effect on improving psychological well-being and life engagement. The Antroyun group showed faster and more marked improvements in earlier follow-ups, while the autogenic relaxation group demonstrated sustained benefits in later follow-ups. The control group did not show any significant changes over time. Additionally, in the Antroyun group, the number of game wins was positively correlated with improvements in psychological well-being and life engagement scores.\n\nThis study was carried out as part of a doctoral dissertation at Sivas Cumhuriyet University.', 'detailedDescription': 'This study was registered retrospectively due to its nature as a doctoral dissertation and institutional administrative timelines. Although participant enrollment and data collection had already started, the study protocol and outcome measures were pre-specified and ethically approved prior to implementation. No interim analysis was conducted prior to registration. This registration is intended to enhance research transparency and integrity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years or older\n* Residing in a nursing home\n* Able to communicate and follow instructions\n* Scoring 24 or above on the Standardized Mini Mental Test (SMMT)\n* Voluntary participation and written informed consent obtained\n\nExclusion Criteria:\n\n* Diagnosed with advanced cognitive impairment (SMMT score \\< 24)\n* Diagnosed with severe psychiatric disorders (e.g., schizophrenia, severe depression)\n* Having physical disabilities that prevent participation in the interventions (e.g., immobility, severe visual or auditory loss)\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06965959', 'briefTitle': 'THE EFFECT OF EXERGAMING APPLICATION AND AUTOGENIC RELAXATION TECHNIQUE ON PSYCHOLOGICAL WELL-BEING AND LIFE ENGAGEMENT OF NURSING HOME RESIDENTS: A RANDOMİZED CONTROLLED TRİAL', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'THE EFFECT OF EXERGAMING APPLICATION AND AUTOGENIC RELAXATION TECHNIQUE ON PSYCHOLOGICAL WELL-BEING AND LIFE ENGAGEMENT OF NURSING HOME RESIDENTS', 'orgStudyIdInfo': {'id': '2023-04/50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exergaming Intervention Group', 'description': 'Participants in this group engaged in exergaming sessions using motion-based digital games (e.g., table tennis, boxing, skiing) twice per week for 8 weeks.', 'interventionNames': ['Behavioral: Exergaming Intervention Group']}, {'type': 'EXPERIMENTAL', 'label': 'Autogenic Relaxation Intervention Group', 'description': 'Participants in this group practiced autogenic relaxation twice per week for 8 weeks in small groups guided by verbal instructions', 'interventionNames': ['Behavioral: Autogenic Relaxation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group received no intervention and continued their usual routine.'}], 'interventions': [{'name': 'Exergaming Intervention Group', 'type': 'BEHAVIORAL', 'description': 'A behavioral intervention involving the use of motion-based digital games such as table tennis, boxing, skiing, and bowling. Participants performed exergaming sessions twice per week for eight weeks. Each session lasted approximately 15 minutes and was conducted in pairs under supervision. The intervention aimed to promote physical activity, cognitive engagement, and social interaction among older adults in a nursing home setting.', 'armGroupLabels': ['Exergaming Intervention Group']}, {'name': 'Autogenic Relaxation', 'type': 'BEHAVIORAL', 'description': 'A behavioral mind-body intervention in which participants practiced standardized verbal relaxation techniques focused on passive concentration and bodily awareness. Sessions were conducted in quiet rooms in small groups, twice per week for eight weeks, each lasting approximately 15 minutes. The goal was to enhance psychological well-being and reduce emotional tension in institutionalized older adults.', 'armGroupLabels': ['Autogenic Relaxation Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'state': 'Central', 'country': 'Turkey (Türkiye)', 'facility': 'Sivas Cumhuriyet University, Institute of Health Sciences', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student in Nursing', 'investigatorFullName': 'Mehtap Budak', 'investigatorAffiliation': 'Cumhuriyet University'}}}}