- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340229
Effects of Laughter Yoga in Mothers of PICU Patients
Effects of Laughter Yoga on Psychological Resilience and Coping Attitudes in Mothers of Children in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
Study Overview
Detailed Description
Having a child hospitalized in a pediatric intensive care unit (PICU) is a highly stressful experience for parents, particularly mothers, and is often associated with increased psychological distress, reduced resilience, and ineffective coping strategies. Despite the critical importance of supporting parental mental well-being in PICU settings, there is a lack of evidence-based, non-pharmacological interventions that simultaneously target resilience and coping attitudes.
This study aimed to evaluate the effect of laughter yoga on resilience and coping attitudes in mothers of children in the pediatric intensive care unit.
A single-blind, parallel-group randomized controlled trial was conducted with the mothers of children hospitalized in the PICU for at least one week. Mothers in the intervention group participated in structured laughter yoga sessions lasting 15-20 minutes over 3-4 days, while the control group received routine care only. Data were collected using the Connor-Davidson Resilience Scale and the Coping Attitudes Assessment Scale before and after the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Izmir, Turkey (Türkiye)
- Buca Seyfi Demirsoy Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers aged 18 years or older
- Ability to read and speak Turkish
- Having a child hospitalized in the pediatric intensive care unit (PICU) for at least one week
- Access to basic communication tools (telephone and/or internet)
- No previous participation in laughter yoga or a similar intervention
Exclusion Criteria:
- Presence of a clinically diagnosed severe psychiatric disorder
- Having a child who was terminally ill or clinically unstable
- Participation deemed inappropriate by the attending physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter Yoga Group
Mothers in the intervention group participated in structured laughter yoga sessions lasting 15-20 minutes, conducted over a period of 3-4 days.
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Mothers in the intervention group participated in structured laughter yoga sessions lasting 15-20 minutes, conducted over a period of 3-4 days.
|
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No Intervention: Control Group
The control group received routine care only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Connor-Davidson Resilience Scale
Time Frame: Six months
|
The Connor-Davidson Resilience Scale (CD-RISC-10) was originally developed by Connor and Davidson (2003), subsequently shortened to 10 items by Campbell-Sills and Stein (2007), and adapted to Turkish by Sarıçam (2010).
The scale is scored using a five-point Likert-type format (0-4), with higher total scores indicating greater resilience.
In the Turkish validity and reliability study, the scale was reported to have a single-factor structure with a Cronbach's alpha coefficient of 0.81.
In the present study, Cronbach's alpha coefficients were 0.79 for the pre-test and 0.80 for the post-test.
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Six months
|
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Coping Attitudes Assessment Scale
Time Frame: six months
|
The scale was originally developed by Carver et al. (1989) and adapted into Turkish by Dicle and Ersanlı (2015).
The adapted version consists of 32 items and 5 subscales: Self-Help, Approach, Adaptation, Avoidance-Escape, and Self-Punishment.
Items are rated on a four-point Likert-type scale, with higher total scores indicating more effective coping attitudes.
In the Turkish validity and reliability study, the overall internal consistency coefficient was reported as 0.97, with Cronbach's alpha values for the subscales ranging from 0.96 to 0.99.
In the present study, the overall internal consistency of the scale was 0.78 in the pre-test and 0.81 in the post-test, while Cronbach's alpha values for the subscales ranged between 0.79 and 0.82.
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six months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDU-NURSING-SD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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