NCT07119164

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

15 days

First QC Date

July 21, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

Laughter YogaIntellectual DisabilitySelf EfficacyParentsBurnoutStress

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    4 weeks

  • stress

    Stress levels were assessed by analyzing salivary cortisol concentrations.

    4 weeks

Study Arms (2)

"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.

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.

Interventions

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.

"Laughter yoga intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale Üniversitesi

Denizli, Kınıklı, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intellectual DisabilityBurnout, Psychological

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study includes one intervention group and one control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant (PhD Candidate)

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 12, 2025

Study Start

April 15, 2025

Primary Completion

April 30, 2025

Study Completion

May 15, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations