Laughter YogaNCT07119164
Laughter Yoga's Impact on Parental Stress, Burnout, and Self-Efficacy
A study testing Laughter yoga in people with Laughter Yoga and Intellectual Disability, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The present study aims to investigate the effects of laughter yoga on stress levels, burnout, and parental self-efficacy among parents of children with intellectual disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga, Intellectual Disability, Parents
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 May 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of children enrolled in the school where the study was conducted
- Parents of children diagnosed with moderate to severe intellectual disability
- Parents who are at least literate
- Parents who can speak and understand Turkish
- Parents with no prior experience in laughter yoga
Who cannot join
- Parents who have undergone abdominal surgery in the past three months, or those with uncontrolled hypertension, glaucoma, hernia, or epilepsy
- Parents diagnosed with endocrine disorders such as Cushing's or Addison's disease
- Parents on continuous medication (e.g., glucocorticoids, antidepressants, insulin, or oral antidiabetics)
- Pregnant parents
- Parents with hearing, vision, speech, or intellectual disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale Üniversitesi
Denizli, Kınıklı, 20160
About this study
Official title: The Effect of Laughter Yoga Applied to Parents of Mentally Disabled Children on Stress Level, Burnout and Parental Self-Efficacy
The present study aims to investigate the effects of laughter yoga on stress levels, burnout, and parental self-efficacy among parents of children with intellectual disabilities.
The specific hypotheses of the study are as follows:
Read more
Hypothesis 1: The mean salivary cortisol levels of the intervention group will be significantly lower than those of the control group.
Hypothesis 2: The perceived stress levels of the intervention group will be significantly lower than those of the control group.
Hypothesis 3: The parental self-efficacy levels of the intervention group will be significantly higher than those of the control group.
Hypothesis 4: The burnout levels of the intervention group will be significantly lower than those of the control group.
To assess the effectiveness of the laughter yoga intervention, participants in the intervention group will be compared to a control group of parents who also have children with intellectual disabilities but will not receive any form of intervention. The intervention will consist of a total of eight laughter yoga sessions, conducted twice a week over a four-week period.
- Conditions
- Laughter Yoga, Intellectual Disability, Parents, Burnout, Self Efficacy, Stress
- Being tested
- Laughter yoga
- Keywords
- Laughter Yoga, Intellectual Disability, Self Efficacy, Parents, Burnout, Stress
- Medical subject headings
- Intellectual Disability, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
Laughter yoga is a mind-body practice that combines unconditional laughter with yogic breathing techniques (known as pranayama). Developed by Dr. Madan Kataria in 1995, the practice is based on the principle that voluntary laughter can provide similar physiological and psychological benefits as spontaneous laughter. It is typically conducted in group sessions involving eye contact, playful behavior, and laughter exercises, which aim to reduce stress, enhance mood, and promote overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| "Laughter yoga intervention group | Experimental | A total of 32 mothers who met the inclusion criteria comprised the intervention group and received a total of eight laughter yoga sessions. The laughter yoga intervention was delivered by a researcher certified as a laughter yoga instructor. The intervention protocol was developed within a structured program framework, with each session conducted according to standardized and pre-established guidelines. The laughter yoga sessions encompassed clapping and warm-up exercises, diaphragmatic breathing techniques, incorporation of elements fostering childlike joy and playfulness, as well as guided laughter exercises. Receives: Other: Laughter yoga |
| Control group | No intervention | Thirty-two mothers who met the inclusion criteria constituted the control group. No intervention was administered to the control group. Since the laughter yoga sessions were conducted in a closed environment, the risk of transmission through sound and visual contact was prevented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy
The scale uses a 7-point Likert-type rating system and consists of 17 items. The total score ranges from a minimum of 17 to a maximum of 119. Higher scores indicate higher levels of self-efficacy. The Cronbach's Alpha internal consistency coefficient of the scale was found to be 0.95.
When examining the findings related to the reliability and validity of the scale, it was found-contrary to the original version-that the scale has a unidimensional structure. It has been determined to be a valid and reliable tool for assessing the parental self-efficacy levels of mothers and fathers of children with moderate to severe intellectual disabilities in Turkey.
Measured: 4 weeks
burnout
The items are rated on a 4-point scale based on how frequently participants experience the emotions described in the items, ranging from 0 ("never") to 4 ("every day"). The scale consists of two subdimensions: Emotional Exhaustion and Personal Accomplishment.
The Emotional Exhaustion subscale includes 13 items and has a reliability coefficient of 0.80. Higher average scores on this subscale indicate greater levels of burnout. The Personal Accomplishment subscale consists of 8 items, also with a reliability coefficient of 0.80. Unlike the Emotional Exhaustion subscale, lower average scores on the Personal Accomplishment subscale indicate a higher level of experienced burnout.
Measured: 4 weeks
Perceived stress
The internal consistency coefficient of the scale was calculated as 0.84, and the test-retest reliability coefficient was found to be 0.87. The scale consists of 14 items and is rated on a 5-point Likert-type scale. The total score obtained from the sum of the items reflects the respondent's perceived level of stress, with higher scores indicating a higher level of perceived stress.
Measured: 4 weeks
stress
Stress levels were assessed by analyzing salivary cortisol concentrations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Apr 2025
- Primary completion30 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laughter YogaStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- The study includes one intervention group and one control group.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Bakırlıoğlu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119164
- Sponsor's protocol ID
- PamukkaleU-SBE-BB-02
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga Applied to Parents of Mentally Disabled Children on Stress Level, Burnout and Parental Self-Efficacy
- ClinicalTrials.gov ID
- NCT07119164
- Acronym / sponsor ID
- PamukkaleU-SBE-BB-02
- Conditions
- Laughter Yoga, Intellectual Disability, Parents, Burnout, Self Efficacy, Stress
- Keywords
- Laughter Yoga, Intellectual Disability, Self Efficacy, Parents, Burnout, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 12 Aug 2025 (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.
The present study aims to investigate the effects of laughter yoga on stress levels, burnout, and parental self-efficacy among parents of children with intellectual disabilities.
The specific hypotheses of the study are as follows:
Hypothesis 1: The mean salivary cortisol levels of the intervention group will be significantly lower than those of the control group.
Hypothesis 2: The perceived stress levels of the intervention group will be significantly lower than those of the control group.
Hypothesis 3: The parental self-efficacy levels of the intervention group will be significantly higher than those of the control group.
Hypothesis 4: The burnout levels of the intervention group will be significantly lower than those of the control group.
To assess the effectiveness of the laughter yoga intervention, participants in the intervention group will be compared to a control group of parents who also have children with intellectual disabilities but will not receive any form of intervention. The intervention will consist of a total of eight laughter yoga sessions, conducted twice a week over a four-week period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes one intervention group and one control group.
| Arm | Type | Receives |
|---|---|---|
| "Laughter yoga intervention group | Experimental | Other: Laughter yogaA total of 32 mothers who met the inclusion criteria comprised the intervention group and received a total of eight laughter yoga sessions. The laughter yoga intervention was delivered by a researcher certified as a laughter yoga instructor. The intervention protocol was developed within a structured program framework, with each session conducted according to standardized and pre-established guidelines. The laughter yoga sessions encompassed clapping and warm-up exercises, diaphragmatic breathing techniques, incorporation of elements fostering childlike joy and playfulness, as well as guided laughter exercises. |
| Control group | No intervention | –Thirty-two mothers who met the inclusion criteria constituted the control group. No intervention was administered to the control group. Since the laughter yoga sessions were conducted in a closed environment, the risk of transmission through sound and visual contact was prevented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parents of children enrolled in the school where the study was conducted
- Parents of children diagnosed with moderate to severe intellectual disability
- Parents who are at least literate
- Parents who can speak and understand Turkish
- Parents with no prior experience in laughter yoga
Key exclusion criteria (5 listed)
- Parents who have undergone abdominal surgery in the past three months, or those with uncontrolled hypertension, glaucoma, hernia, or epilepsy
- Parents diagnosed with endocrine disorders such as Cushing's or Addison's disease
- Parents on continuous medication (e.g., glucocorticoids, antidepressants, insulin, or oral antidiabetics)
- Pregnant parents
- Parents with hearing, vision, speech, or intellectual disabilities
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 yogaLaughter yoga is a mind-body practice that combines unconditional laughter with yogic breathing techniques (known as pranayama). Developed by Dr. Madan Kataria in 1995, the practice is based on the principle that voluntary laughter can provide similar physiological and psychological benefits as spontaneous laughter. It is typically conducted in group sessions involving eye contact, playful behavior, and laughter exercises, which aim to reduce stress, enhance mood, and promote overall well-being. | Other | "Laughter yoga intervention group |
Primary outcome
self-efficacy
Time frame: 4 weeks
The scale uses a 7-point Likert-type rating system and consists of 17 items. The total score ranges from a minimum of 17 to a maximum of 119. Higher scores indicate higher levels of self-efficacy. The Cronbach's Alpha internal consistency coefficient of the scale was found to be 0.95. When examining the findings related to the reliability and validity of the scale, it was found-contrary to the original version-that the scale has a unidimensional structure. It has been determined to be a valid and reliable tool for assessing the parental self-efficacy levels of mothers and fathers of children with moderate to severe intellectual disabilities in Turkey.
burnout
Time frame: 4 weeks
The items are rated on a 4-point scale based on how frequently participants experience the emotions described in the items, ranging from 0 ("never") to 4 ("every day"). The scale consists of two subdimensions: Emotional Exhaustion and Personal Accomplishment. The Emotional Exhaustion subscale includes 13 items and has a reliability coefficient of 0.80. Higher average scores on this subscale indicate greater levels of burnout. The Personal Accomplishment subscale consists of 8 items, also with a reliability coefficient of 0.80. Unlike the Emotional Exhaustion subscale, lower average scores on the Personal Accomplishment subscale indicate a higher level of experienced burnout.
Perceived stress
Time frame: 4 weeks
The internal consistency coefficient of the scale was calculated as 0.84, and the test-retest reliability coefficient was found to be 0.87. The scale consists of 14 items and is rated on a 5-point Likert-type scale. The total score obtained from the sum of the items reflects the respondent's perceived level of stress, with higher scores indicating a higher level of perceived stress.
stress
Time frame: 4 weeks
Stress levels were assessed by analyzing salivary cortisol concentrations.
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Laughter Yoga and Intellectual Disability, run by Pamukkale 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 5 inclusion and 5 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 12 Aug 2025. 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?
self-efficacy (time frame: 4 weeks). 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 12 Aug 2025.