CaregiverNCT07314463
The Psychobiological Effects of Laughter Yoga: An Intervention Study
A study testing Laughter Yoga-Based Mental Health Strengthening Training in people with Caregiver and Education, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- Laughter Yoga-Based Mental Health Strengthening Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2024to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having participated in a similar program within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Directorate of National Education
Konya, Selcuklu, 42130
About this study
Official 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
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.
Read the 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.
- Being tested
- Laughter Yoga-Based Mental Health Strengthening Training
- Keywords
- Laughter Yoga, Strengthening Mental Health, Caregiver Burden, Positive Mental Health, Stress
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter Yoga-Based Mental Health Strengthening TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after the initial assessment
Positive Mental Health Scale
It is used to define and assess positive mental health.
Measured: 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.
Measured: 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.
Measured: Every week for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start3 Dec 2024
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Erdem, Selcuk University
- Investigators
- Arzu K UYAROĞLU, Associate Professor, Study director, Selcuk UniversityÖzlem ERDEM, MSC, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314463
- Sponsor's protocol ID
- 24112002
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07314463
- Acronym / sponsor ID
- 24112002
- Keywords
- Laughter Yoga, Strengthening Mental Health, Caregiver Burden, Positive Mental Health, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Strengthening mental health | Experimental | Behavioral: Laughter Yoga-Based Mental Health Strengthening TrainingThe 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Having participated in a similar program within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter Yoga-Based Mental Health Strengthening TrainingThis 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. | Behavioural | Experimental: Strengthening mental health |
Primary outcome
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.
Positive Mental Health Scale
Time frame: 8 weeks after the initial assessment
It is used to define and assess positive mental health.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu K UYAROĞLU, Associate Professor study director
Selcuk University
Özlem ERDEM, MSC principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga-Based Mental Health Strengthening Training in people with Caregiver and Education, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiving Burden Scale (time frame: 8 weeks after the initial assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.