NCT07015372

Brief Summary

This study aims to examine the effects of laughter yoga on general health, perceived stress, and burnout among psychiatric nurses. Nurses working in psychiatric units are often exposed to high levels of occupational stress, which may impact their well-being and job performance. This trial was designed to evaluate the potential benefits of laughter yoga as a supportive intervention in this context.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 5, 2025

Last Update Submit

June 8, 2025

Conditions

Keywords

Laughter YogaMaslach Burnout InventoryPSS-10GHQ-28Psychiatric NursesNursing InterventionsMental Health PromotionComplementary TherapiesBurnout PreventionStress ReductionWorkplace Wellness

Outcome Measures

Primary Outcomes (3)

  • Change in Maslach Burnout Inventory (MBI) Total Score

    The Maslach Burnout Inventory (MBI) is used to assess burnout levels among psychiatric nurses. Scores range from low to high burnout. A decrease in score indicates reduced burnout. The scale has three subscales: emotional exhaustion, depersonalization, and personal accomplishment.

    Baseline and after 4 weeks (post-intervention)

  • Change in Perceived Stress Level (PSS-10 Total Score)

    Perceived stress is measured using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in score reflects improvement.

    Baseline and Week 4 (post-intervention)

  • Change in General Health Status (GHQ-28 Total Score)

    General health is evaluated using the General Health Questionnaire-28 (GHQ-28), which includes somatic symptoms, anxiety/insomnia, social dysfunction, and severe depression subscales. Total scores range from 0 to 28, with lower scores indicating better general health status.

    Baseline and Week 4 (post-intervention)

Study Arms (2)

Experimental: Laughter Yoga

EXPERIMENTAL

Participants in this group received a structured laughter yoga program consisting of 8 sessions over approximately four weeks. Each session lasted about 30 minutes and included clapping, breathing exercises, playful activities, and laughter exercises. Sessions were delivered face-to-face in small groups.

Behavioral: Laughter Yoga

Control: No Intervention

NO INTERVENTION

Participants in this group did not receive any intervention during the study period. They continued their usual routines and duties. The same pre- and post-test assessments were applied as in the experimental group.

Interventions

Laughter YogaBEHAVIORAL

Laughter yoga intervention including clapping, breathing, childlike play, and laughter exercises, delivered in 8 sessions over 4 weeks to reduce stress and burnout and improve general health among psychiatric nurses.

Experimental: Laughter Yoga

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a psychiatric nurse at the specified hospital
  • Volunteering to participate
  • Not receiving psychiatric treatment currently

You may not qualify if:

  • Chronic physical illnesses that could interfere
  • Inability to attend all sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erenköy Ruh ve Sinir Hastalıkları Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burnout, PsychologicalOccupational Stress

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayşe V Dost

    Bezmialem Vakıf Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. No parties were masked during the intervention or outcome assessment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to two parallel groups: an experimental group receiving a structured laughter yoga program, and a control group receiving no intervention during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 11, 2025

Study Start

July 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the dataset is currently being used for the preparation of a scientific publication. Data sharing may be considered after the publication process is complete, upon reasonable request and with appropriate approvals.

Locations