Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-25 @ 2:02 AM
Study NCT ID:
NCT07235735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000068376', 'term': 'Compassion Fatigue'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D027641', 'term': 'Laughter Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress (Perceived Stress Scale - PSS)', 'timeFrame': 'Baseline, 8 weeks, 3 months.', 'description': 'Developed by Cohen \\& Williamson, adapted to Turkish by Eskin in 2013. 14 items, single-factor measure of stress.\n\nScale Range: 0-56. Interpretation Higher scores = greater perceived stress (worse outcome).'}, {'measure': 'Burnout Levels (Maslach Burnout Inventory - MBI)', 'timeFrame': 'Baseline, immediately post-intervention (8 weeks), and follow-up (3 months after intervention).', 'description': 'Developed by Maslach \\& Jackson in 1986, adapted to Turkish by Ergin in1992. 22 items, three subscales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment.\n\nScale Range: Emotional Exhaustion (0-54), Depersonalization (0-30), Personal Accomplishment (0-48).\n\nInterpretation: Higher Emotional Exhaustion and Depersonalization scores = worse outcome; higher Personal Accomplishment scores = better outcome.'}], 'secondaryOutcomes': [{'measure': 'Problem Solving Inventory', 'timeFrame': 'Baseline, 8 weeks, 3 months', 'description': 'Problem Solving Inventory, Developed by Heppner \\& Peterson in1982; adapted to Turkish by Şahin in 1993\n\nDescription: 31 items, six subscales: Problem-Solving Confidence, Approach-Avoidance, Personal Control, Planfulness, Impulsivity, Reflective Style.\n\nScale Range: 31-186. Interpretation: Higher scores = less effective problem solving (worse outcome); lower scores = better problem-solving skills.'}, {'measure': 'Work Performance', 'timeFrame': 'Baseline, 8 weeks, 3 months.', 'description': 'Work Performance Job Performance Scale - Goodman and Svyantek in 1999; Turkish adaptation was made in 2014 by Bağcı.\n\nDescription: 25 items, two subscales: Task Performance and Contextual Performance.\n\nScale Range: 25-125. Interpretation: Higher scores = better work performance.'}, {'measure': 'Compassion Fatigue', 'timeFrame': 'Baseline, 8 weeks, 3 months', 'description': 'Developed by Dennis Portnoy and adapted Turkısh by Özdemir and Kutlu in 2022. The form consists of 40 items. The scale, which has no sub-dimensions, is evaluated based on the total number of items. The scale is a 3-point Likert-type scale: 1 = Very true, 2 = Partly true, and 3 = Rarely true. Those who answered "Very true" to 15 or more items in total are considered to have high levels of compassion fatigue.Cronbach alpha is 0,87'}, {'measure': 'Decision-Making Styles scale', 'timeFrame': 'Baseline, 8 weeks, 3 months.', 'description': 'Developed by Scott and Bruce in 1995; adapted to Turkish by Yılmaz Kuşaklı in 2023\n\n24 items, five subscales: Rational, Intuitive, Dependent, Avoidant, Spontaneous.\n\nScale Range: 24-120. Interpretation: Higher scores in each subscale = more frequent use of that decision-making style'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nurse Managers', 'Laughter Yoga', 'Burnout', 'Stress', 'Work-Life Balance', 'Decision Making', 'Problem Solving', 'Job Performance', 'Compassion Fatigue', 'Conflict Management', 'Organizational Outcomes', 'Professional Development'], 'conditions': ['Burnout, Professional', 'Stress, Psychological', 'Compassion Fatigue', 'Quality of Life', 'Decision Making', 'Problem Solving', 'Work Performance']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://scholar.google.com.tr/scholar?hl=tr&as_sdt=0%2C5&q=Status+and+influencing+factors+of+work+stress+among+nurse+managers%3A+A+cross-sectional+study+in+China&btnG=', 'label': 'Yang, Z., Huang, H., \\& Li, G. (2024). Status and influencing factors of work stress among nurse managers in western China: a cross-sectional survey study. BMC nursing, 23(1), 68.'}, {'url': 'https://scholar.google.com.tr/scholar?hl=tr&as_sdt=0%2C5&as_vis=1&q=The+effects+of+laughter+yoga+on+health-related+outcomes%3A+A+systematic+review.+Complementary+Therapies+in+Clinical+Practice&btnG=', 'label': 'Alici, N. K., \\& Dönmez, A. A. (2020). A systematic review of the effect of laughter yoga on physical function and psychosocial outcomes in older adults. Complementary therapies in clinical practice, 41, 101252.'}, {'url': 'https://scholar.google.com/scholar?hl=tr&as_sdt=0%2C5&q=Maslach%2C+C.%2C+%26+Jackson%2C+S.+E.+%281981%29.+The+measurement+of+experienced+burnout.+Journal+of+organizational+behavior%2C+2%282%29%2C+99-113.&btnG=', 'label': 'Maslach, C., \\& Jackson, S. E. (1981). The measurement of experienced burnout. Journal of organizational behavior, 2(2), 99-113.'}, {'url': 'https://cir.nii.ac.jp/crid/1570291225076829312', 'label': 'Ergin, C. (1992). Doktor ve hemsirelerde tukenmislik ve Maslach tukenmislik olceginin uyarlanmasi. VII. Ulusal Psikoloji Kongresi, 22th September 1992 Ankara (Turkey).'}, {'url': 'https://dergipark.org.tr/en/pub/yead/issue/21807/234392', 'label': 'Bağcı, Z. (2014). ÇALIŞANLARIN İŞ DOYUMUNUN GÖREV VE BAĞLAMSAL PERFORMANSLARI ÜZERİNDEKİ ETKİSİ. Yönetim ve Ekonomi Araştırmaları Dergisi, 12(24), 58-72.'}, {'url': 'https://www.turkiyeklinikleri.com/article/en-sefkat-yorgunlugu-olceginin-hemsireler-uzerinde-turkce-gecerlilik-ve-guvenilirligi-calismasi-metodolojik-arastirma-98273.html', 'label': "UÇAR ÖZDEMİR, S., \\& KOCA KUTLU, A. (2022). Şefkat Yorgunluğu Ölçeği'nin Hemşireler Üzerinde Türkçe Geçerlilik ve Güvenilirliği Çalışması: Metodolojik Araştırma. Turkiye Klinikleri Journal of Nursing Sciences, 14(2)."}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if laughter yoga can improve both individual and organizational outcomes in nurse managers. The main questions it aims to answer are:\n\n* Does laughter yoga lower burnout and stress levels in nurse managers?\n* Does laughter yoga improve work-life quality and job performance?\n* Does laughter yoga help nurse managers make better decisions and solve problems more effectively?\n* Does laughter yoga lower compassion fatigue and support positive approaches to workplace conflict? Researchers will compare a laughter yoga group with a control group to see if there are meaningful differences.\n\nParticipants will:\n\n* Join structured laughter yoga sessions for a defined period (weekly sessions).\n* Complete surveys before and after the program about stress, burnout, work-life quality, decision-making, problem solving, job performance, compassion fatigue, and conflict approaches.\n* Continue their usual work while attending sessions.', 'detailedDescription': "Nurse managers play a vital role in healthcare systems by ensuring the quality of nursing services, supporting staff, coordinating care, and solving organizational problems. However, the combination of administrative responsibilities, staff shortages, and high expectations often leads to stress, burnout, compassion fatigue, and difficulties in maintaining work-life balance. These conditions not only affect the individual health and well-being of nurse managers but also reduce team motivation, patient care quality, and overall organizational performance.\n\nLaughter yoga is a mind-body practice that combines intentional laughter with breathing exercises. It does not rely on humor or jokes; instead, participants engage in guided group exercises that promote spontaneous and prolonged laughter. Scientific evidence suggests that laughter yoga can lower stress hormones, increase endorphins, improve mood, and strengthen social bonds. Although laughter yoga has been studied in various populations, there is a lack of randomized controlled trials (RCTs) specifically focusing on nurse managers and their professional challenges.\n\nThis randomized controlled trial aims to fill this gap by evaluating the individual and organizational outcomes of laughter yoga among nurse managers working in university and state hospitals.\n\nThe expected contribution of this study is to provide new evidence on a cost-effective, non-pharmacological intervention that can be easily integrated into hospital settings. If laughter yoga proves effective, it can be adopted as a sustainable strategy to support nurse managers' mental health, enhance their leadership capacity, and indirectly improve patient care and organizational outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently working as a nurse manager\n* Having at least six months of managerial experience\n* Continuing to serve as a nurse manager throughout the study period\n\nExclusion Criteria:\n\n* Having previously received laughter yoga training\n* Use of medications affecting general health components during the study (e.g., for depression, anxiety)\n* Being pregnant\n* Experiencing an acute stressful life event, such as the death of a close relative\n* Having undergone abdominal surgery within the past 6 months'}, 'identificationModule': {'nctId': 'NCT07235735', 'briefTitle': 'The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers: A Longitudinal Study', 'orgStudyIdInfo': {'id': 'Laughter Yoga'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Laughter Yoga', 'description': 'Structured group-based laughter yoga sessions, 2 times per week, 30-45 minutes each, for 8 weeks.', 'interventionNames': ['Behavioral: Laughter Yoga Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants continue their routine work duties without any additional intervention.'}], 'interventions': [{'name': 'Laughter Yoga Program', 'type': 'BEHAVIORAL', 'otherNames': ['Laughter Therapy;', 'Laughter Exercises'], 'description': 'This intervention consists of a structured Laughter Yoga Program designed for nurse managers. Each session includes breathing exercises, warm-up activities, guided and simulated laughter exercises (such as clapping, chanting, role-play laughter), and a short relaxation/meditation phase. Sessions are conducted in small groups by a certified facilitator. The program is delivered twice weekly for 8 weeks, with each session lasting approximately 30-45 minutes. The intervention is intended to reduce burnout, stress, and compassion fatigue, while improving decision-making, problem-solving, job performance, and work-life balance.', 'armGroupLabels': ['Experimental: Laughter Yoga']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Serpil SUBAŞI ÇAĞLAR, PhDCandidate', 'role': 'CONTACT', 'email': 'serpilkercaglar@hotmail.com', 'phone': '+905321709457'}, {'name': 'Handan ALAN, Assoc.Prof.', 'role': 'CONTACT', 'email': 'handanalan@yahoo.com', 'phone': '+905321709457'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in the department of nursing management', 'investigatorFullName': 'SERPİL SUBAŞI ÇAĞLAR', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}