The Psychobiological Effects of Laughter Yoga: An Intervention Study

NCT ID: NCT07314463

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2025-01-23

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.

Detailed Description

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.

Conditions

Caregiver; Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Strengthening mental health

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.

Group Type: EXPERIMENTAL

Laughter Yoga-Based Mental Health Strengthening Training

Intervention Type: 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.

No İntervention

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laughter Yoga-Based Mental Health Strengthening Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Erdem

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu K UYAROĞLU, Associate Professor

Role: STUDY_DIRECTOR

Selcuk University

Özlem ERDEM, MSC

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Directorate of National Education

Konya, Selcuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

24112002

Identifier Type: -

Identifier Source: org_study_id