The Psychobiological Effects of Laughter Yoga: An Intervention Study

December 17, 2025 updated by: Özlem Erdem, Selcuk University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Selcuklu
      • Konya, Selcuklu, Turkey (Türkiye), 42130
        • Directorate of National Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks after the initial assessment
Positive Mental Health Scale
Time Frame: 8 weeks after the initial assessment
It is used to define and assess positive mental health.
8 weeks after the initial assessment
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.
8 weeks after the initial assessment
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.
Every week for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arzu K UYAROĞLU, Associate Professor, Selcuk University
  • Principal Investigator: Özlem ERDEM, MSC, Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24112002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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