NCT06827015

Brief Summary

This study aims to evaluate the effects of laughter yoga on anger levels and mental well-being in schoolchildren. Research indicates that laughter yoga has the potential to reduce stress and improve communication skills. There have been few studies specifically targeting children with high anger levels and low mental well-being. This study focuses on children under stress or with limited social support. Laughter yoga is a fun and effective technique that can be easily integrated into children's daily lives. The study is expected to provide positive contributions to the educational environment and reduce behavioral issues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 10, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

ANGERLAUGHTER YOGASPIRITUAL WELL-BEINGSCHOOL AGE CHILDREN

Outcome Measures

Primary Outcomes (2)

  • Emotion Regulation Scale for Children (ÇDDÖ)

    Emotion Regulation Scale for Children (ÇDDÖ) is designed to assess emotion regulation skills in children aged 8-12. The scale consists of four subscales: Anger (9 items), Excitement (5 items), Fear (8 items), and Sadness (7 items). Each item is rated using a 4-point Likert scale ranging from 1 (does not describe me at all) to 4 (describes me completely). In the reliability and validity study of the Turkish version, the Cronbach's Alpha coefficient was found to be 0.85 for the overall scale. Additionally, there are reverse-scored items (Anger items: 2, 9; Excitement items: 4, 5; Fear items: 3, 6, 7).An increase in the total score indicates an improvement in emotion regulation levels. The average score is 79.50 ± 11.11. Scores below 68.39 indicate poor emotion regulation skills, while scores above 90.61 indicate a positive condition. The ÇDDÖ is planned to be administered on three different occasions: as a pre-test,post-test, and one-month follow-up.

    2 MONTHS

  • Mental Well-Being Survey

    This survey study aims to evaluate children's daily emotional states using a visual tool. Every day before going to bed, children select the expression that best reflects their emotional state. For evaluation, five facial expressions rated from 1 (very sad) to 5 (very happy) will be used. The scores of the facial expressions selected each day will be collected over a period of 30 days. The collected scores will help determine whether a child's mood trends positively or negatively. In the planned study, the minimum score will be 5, and the maximum score will be 25. Based on these scores, values above the average will be considered indicators of a positive mood, while values below the average will be viewed as signs of a negative emotional state. The study is planned to include a 4-week measurement and subsequently the first-month measurements.

    2 Months

Study Arms (2)

Group Receiving Laughter Yoga

EXPERIMENTAL

Eight Laughter Yoga Sessions, Each Lasting 40 Minutes, Conducted Twice a Week, for Students with High Anger Levels

Behavioral: Laughter-Based Anger Reduction Program

Group Without Any Intervention

NO INTERVENTION

Participants Receiving No Intervention to Assess Baseline Anger Levels

Interventions

This intervention involves structured Laughter Yoga sessions lasting 40 minutes each, conducted twice a week. It specifically targets students with high anger levels. The program combines breathing exercises, playful laughter activities, and relaxation techniques to reduce stress and promote emotional regulation. Unlike other interventions, this program uniquely emphasizes laughter as a tool for managing anger and enhancing overall well-being.

Group Receiving Laughter Yoga

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 8-11,
  • Being a student who regularly attends the school where the study is conducted between February 3 and June 6, when research data is collected,
  • Having written consent from a parent/guardian to participate in the study,
  • Being willing to participate in the study, and
  • Scoring above the median on the Emotion Regulation Scale for Children.

You may not qualify if:

  • Having a diagnosed health problem that could interfere with laughter exercises (respiratory issues, heart conditions, musculoskeletal problems),
  • Having undergone psychological treatment in the last 3 months,
  • Currently participating in another psychological support program, and
  • Scoring below the median on the Emotion Regulation Scale for Children.
  • The criteria for termination of the intervention are not attending two consecutive sessions and non-compliance with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmet Mete Işıkara Primary School

Akdeniz, Mersin, 33010, Turkey (Türkiye)

Location

Hurriyet Primary School

Akdeniz, Mersin, 33010, Turkey (Türkiye)

Location

Study Officials

  • Emine Öncü, Advisor

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Students were randomized into groups based on their classes to prevent information leakage, and using Excel-generated randomization, students with high anger scores were assigned equally (1:1 ratio) to Intervention and Delayed groups. Assignment for each student was determined in sealed envelopes, which were opened after the evaluation, implementing blinding by ensuring that neither the students nor the statisticians were aware of the group allocations.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to intervention (laughter yoga) and control groups. Intervention effects will be measured at baseline and end.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

March 16, 2025

Primary Completion

May 16, 2025

Study Completion

May 25, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

If someone wants to use the data, they will request permission, and it will be shared based on suitability.

Locations