NCT07628569

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 29, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 13, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

yogaValues ClarificationStressParentsEmotional RegulationcomfortSpecial Needs ChildrenNursing Intervention

Outcome Measures

Primary Outcomes (1)

  • Comfort Level

    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 Outcomes (1)

  • Emotional Regulation

    Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up

Other Outcomes (1)

  • Perceived Stress

    Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up

Study Arms (3)

Values Clarification Group

EXPERIMENTAL

Participants in this group will receive a values clarification intervention based on Comfort Theory to support emotional awareness, coping, and psychological well-being.

Behavioral: Values Clarification

Yoga Group

EXPERIMENTAL

A structured yoga intervention delivered over 8 weeks to improve relaxation, emotional regulation, and overall well-being in parents of children with special needs.

Behavioral: Yoga

Control Group

NO INTERVENTION

Participants in this group will not receive any intervention during the study period.

Interventions

YogaBEHAVIORAL

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.

Yoga Group

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.

Values Clarification Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corum New Indoor Sports Hall

Çorum, 19000, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Emotional Regulation

Interventions

Yoga

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Hacer DELİBAŞ, Registered Nurse

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups: a yoga intervention group, a values clarification group, or a control group. Each group will be followed simultaneously during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist nurse

Study Record Dates

First Submitted

May 13, 2026

First Posted

June 5, 2026

Study Start

April 29, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations