- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628569
Effect of Yoga and Values Clarification on Stress, Comfort, and Emotional Regulation in Parents of Children With Special Needs
The Effect of a Comfort Theory-Based Yoga and Values Clarification Intervention on Emotion Regulation, Comfort, and Stress Levels in Parents of Children With Special Needs
Parents of children with special needs often experience high levels of stress and difficulties in emotional regulation, which may negatively affect both their well-being and parent-child interactions. This study aims to evaluate the effect of a Comfort Theory-based yoga and values clarification intervention on emotional regulation, comfort, and perceived stress levels in these parents.
This randomized controlled study will include three groups: a yoga intervention group, a values clarification group, and a control group. Participants will be randomly assigned to groups. Data will be collected using the Emotion Regulation Scale, Perceived Stress Scale, and General Comfort Questionnaire.
The intervention is expected to improve emotional regulation and comfort levels while reducing perceived stress among parents of children with special needs. The findings may contribute to the development of effective nursing interventions to support caregiver well-being.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parents of children with special needs are at increased risk of experiencing stress, anxiety, and emotional difficulties, which may negatively influence both their own well-being and their interactions with their children. Supporting these parents through effective interventions is essential for improving both parent and child outcomes.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a Comfort Theory-based yoga and values clarification intervention. Participants will be parents of children with special needs who meet the inclusion criteria. They will be randomly assigned to one of three groups: a yoga intervention group, a values clarification group, or a control group.
The yoga intervention will include structured sessions aimed at promoting physical relaxation and mental well-being. The values clarification intervention will focus on helping participants identify and reflect on their personal values, enhancing emotional awareness and coping strategies. The control group will not receive any intervention during the study period.
Data will be collected using validated instruments, including the Emotion Regulation Scale, the Perceived Stress Scale, and the General Comfort Questionnaire. These measures will assess changes in emotional regulation, stress, and comfort levels before and after the intervention.
The results of this study are expected to provide evidence on the effectiveness of non-pharmacological, nursing-based interventions in improving psychological well-being among parents of children with special needs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hacer DELİBAŞ, Registered Nurse
- Phone Number: +90 5514128689
- Email: haceeer_91@hotmail.com
Study Locations
-
-
-
Çorum, Turkey (Türkiye), 19000
- Recruiting
- Corum New Indoor Sports Hall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a parent of a child with special needs,
- Not having received prior yoga training,
- Not having a physical problem that would prevent them from practicing yoga,
- Not having communication problems,
- Speaking Turkish,
- Not having learning disabilities,
- Being suitable/willing to work in a group.
Exclusion Criteria for Parents:
- Having a physical problem that would prevent them from practicing yoga,
- The parent not being a volunteer,
- Not demonstrating compatibility with working in a group.
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: Values Clarification Group
Participants in this group will receive a values clarification intervention based on Comfort Theory to support emotional awareness, coping, and psychological well-being.
|
A values clarification intervention based on Comfort Theory delivered over 8 weeks, focusing on helping participants identify personal values, enhance emotional awareness, and develop effective coping strategies to improve psychological well-being.
|
|
Experimental: Yoga Group
A structured yoga intervention delivered over 8 weeks to improve relaxation, emotional regulation, and overall well-being in parents of children with special needs.
|
A structured yoga program delivered over 8 weeks, including breathing exercises, physical postures, and relaxation techniques, aimed at improving emotional regulation, reducing stress, and enhancing overall comfort in parents of children with special needs.
|
|
No Intervention: Control Group
Participants in this group will not receive any intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comfort Level
Time Frame: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Comfort levels will be measured using a validated scale based on Comfort Theory before and after the intervention.
|
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Regulation
Time Frame: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Changes in emotional regulation levels will be assessed using a validated emotional regulation scale before the intervention and after the 8-week intervention period.
|
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Perceived stress levels will be evaluated using a standardized stress scale before and after the 8-week intervention period.
|
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AYBU-SBE-HD-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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