Skip to main content
OpenTrials
Completed

NCT Number: NCT07314463

The Psychobiological Effects of Laughter Yoga: An Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Directorate of National Education

Konya, Selcuklu, 42130, Turkey (Türkiye)

About this study

Individuals with special needs are those with physical, developmental, or behavioral differences and require more intensive and specialized care in areas such as education, healthcare, and social life. Mothers, as the primary caregivers of children, play a significant role in meeting the needs of children with special needs. However, the extraordinary effort exerted by these mothers can become challenging due to various circumstances, leading to increased caregiving burden and difficulties in the physical, emotional, social, or economic areas. During this process, mothers may become vulnerable to mental health problems and may need support to cope with these challenges. Therefore, providing empowerment training to protect and improve the mental health of mothers of children with special needs is essential in the future.

This study was a randomized controlled trial designed with a pre-test post-test experimental design. The study group consisted of mothers of children with special needs who were receiving special education at a Rehabilitation Center in Konya, Turkey. A total of 40 participants were included in the study: 20 in the intervention group and 20 in the control group.

Data collection tools included the Personal Information Form, the Zarit Caregiver Burden Scale, the Positive Mental Health Scale, and the Perceived Stress Scale. Saliva samples were also collected to measure the cortisol levels of the participants. The intervention group received an 8-week Laughter Yoga-Based Mental Health Empowerment Training, administered by the researcher. No intervention was provided to the control group (CG).

Before the study began, ethical approval was obtained from the Non-Invasive Clinical Research Ethics Committee of a university's Faculty of Nursing, institutional permission was received from the Provincial Directorate of National Education, and written informed consent was obtained from all participants.

For data analysis:

  • Independent Sample t-tests were used to compare numerical descriptive variables between groups,
  • Pearson's chi-square and Fisher's exact tests were used for categorical variables.
  • Pearson's correlation coefficients were used to examine the relationships between numerical variables.
  • Mixed-design ANOVA was used to compare changes over time within the groups.
  • Logistic regression analysis was conducted to determine the significant predictors in the intervention group.
  • The strength of the relationship between the dependent and independent variables in the logistic regression was evaluated using Cox-Snell R² and Nagelkerke R².
  • A p-value of <0.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Laughter Yoga-Based Mental Health Strengthening Training

Behavioral

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.

Primary outcomes

  1. Zarit Caregiving Burden Scale

    Time frame: 8 weeks after the initial assessment

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

  2. Positive Mental Health Scale

    Time frame: 8 weeks after the initial assessment

    It is used to define and assess positive mental health.

  3. Perceived Stress Scale

    Time frame: 8 weeks after the initial assessment

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

  4. Salivary cortisol levels

    Time frame: Every week for 8 weeks

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

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effect of Laughter Yoga-Based Mental Health Strengthening Training Applied to Mothers With Children With Special Needs on Caregiving Burden, Positive Mental Health, Perceived Stress and Salivary Cortisol Level

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.