NCT07314463

Brief Summary

This study was conducted to determine the effect of Laughter Yoga-Based Mental Health Enhancement Training, applied to mothers of children with special needs, on the burden of care, positive mental health, perceived stress, and salivary cortisol levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

December 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 6, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Laughter YogaStrengthening Mental HealthCaregiver BurdenPositive Mental HealthStress

Outcome Measures

Primary Outcomes (4)

  • Zarit Caregiving Burden Scale

    It is used to assess the emotional, social, and physical burden an individual experiences as a result of their caregiver role.

    8 weeks after the initial assessment

  • Positive Mental Health Scale

    It is used to define and assess positive mental health.

    8 weeks after the initial assessment

  • Perceived Stress Scale

    It is used to determine the extent to which individuals perceive certain events in their lives as stressful.

    8 weeks after the initial assessment

  • Salivary cortisol levels

    There will be a relationship between laughter yoga-based mental health strengthening training and mothers' salivary cortisol levels.

    Every week for 8 weeks

Study Arms (2)

Experimental: Strengthening mental health

EXPERIMENTAL

The intervention group was divided into two subgroups, each consisting of ten participants. Based on participants' availability, the first group's sessions were scheduled for Tuesdays and the second group's sessions for Thursdays. The reason for dividing The intervention group was divided because the mothers were only available on specific days. This arrangement aimed to ensure more effective participation in the training process and enhance group interaction for more efficient implementation of the training. The same interaction-based intervention was implemented in both intervention subgroups with identical content and formats.

Behavioral: Laughter Yoga-Based Mental Health Strengthening Training

No İntervention

NO INTERVENTION

Participants in the control group were asked to complete a Personal Information Form, the Zarit Caregiver Burden Scale, the Positive Mental Health Scale, and the Perceived Stress Level Scale. Participants in the control group received no intervention. Cortisol saliva samples were collected from participants in the control group simultaneously with the experimental group. Posttests were taken from participants in the control group after the intervention sessions.

Interventions

This laughter yoga-based training program is distinct from traditional practices because of its structured psychoeducational content. In addition to laughter exercises, it aims to enhance participants' self-awareness, stress management, and communication skills through informative and reflective sessions. Each session began with cognitive and emotional awareness-building activities, followed by physical laughter practices, promoting mind-body integration. Thus, the program offers multidimensional benefits, including emotional relief, cognitive development, social skill enhancement, and strengthening internal coping resources.

Experimental: Strengthening mental health

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen were chosen as biological mothers
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being the primary caregiver of the child
  • Having a score of 21 or higher on the Zarit Caregiver Burden Scale
  • Understanding and speaking Turkish at a level sufficient to complete data collection forms and participate in sessions

You may not qualify if:

  • Having participated in a similar program within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Directorate of National Education

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Arzu K UYAROĞLU, Associate Professor

    Selcuk University

    STUDY DIRECTOR
  • Özlem ERDEM, MSC

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective Randomized Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 6, 2025

First Posted

January 2, 2026

Study Start

December 3, 2024

Primary Completion

January 23, 2025

Study Completion

January 23, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations