StressNCT07628569
Effect of Yoga and Values Clarification on Stress, Comfort, and Emotional Regulation in Parents of Children With Special Needs
A study testing Yoga and Values Clarification in people with Stress and Emotional Regulation, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional Regulation, Comfort
- What is being tested?
- Yoga and Values Clarification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2026to 19 Oct 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Emotional Regulation, Comfort
- Being tested
- Yoga, Values Clarification
- Keywords
- yoga, Values Clarification, Stress, Parents, Emotional Regulation, comfort, Special Needs Children, Nursing Intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
Values ClarificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Yoga |
| Control Group | No intervention | Participants in this group will not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Level
Comfort levels will be measured using a validated scale based on Comfort Theory before and after the intervention.The Turkish validity and reliability of the General Comfort Scale, developed by Kolcaba in 1992, were established by Kuğuoğlu and Karabacak (2008). The scale is a four-point Likert-type instrument consisting of a total of 48 items. The comfort levels addressed by the scale are relief (16 items), ease (17 items), and transcendence (15 items). The scale comprises both positive and negative items, with the response format arranged in a mixed order. Accordingly, for positive items, a high score (four) indicates a high level of comfort, while a low score (one) indicates a low level of comfort. When scoring the scale, the scores obtained from negative items are reverse-coded and then summed with the scores from positive items. The maximum possible total score is 192, and the minimum is 48. Low comfort is represented by a score of one, and high comfort by a score of four.
Measured: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
Secondary outcomes (1)
Emotional Regulation
Changes in emotional regulation levels will be assessed using a validated emotional regulation scale before the intervention and after the 8-week intervention periodThe scale is scored on a 7-point Likert scale. It is used in emotion regulation studies and aims to evaluate two emotion regulation strategies. The scale has two factors: items 1, 3, 5, 7, 8, and 10 relate to the re-evaluation factor, while items 2, 4, 6, and 9 relate to the repression subscale. There are no reverse-coded items in the scale. High scores on the subscales indicate high repression or high re-evaluation strategy use. A total score cannot be obtained from the scale (Eldeleklioğlu and Eroğlu, 2015). The lowest possible score for the re-evaluation subscale is 6, and the highest is 42. The lowest possible score for the repression subscale is 4, and the highest is 28.
Measured: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start29 Apr 2026
- Primary completion19 Sep 2026
- Study completion19 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- 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.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Delibaş, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628569
- Sponsor's protocol ID
- AYBU-SBE-HD-01
- Status last verified
- Nov 2026
- First submitted
- 13 May 2026
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07628569
- Acronym / sponsor ID
- AYBU-SBE-HD-01
- Conditions
- Stress, Emotional Regulation, Comfort
- Keywords
- yoga, Values Clarification, Stress, Parents, Emotional Regulation, comfort, Special Needs Children, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 19 Sep 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 5 Jun 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Values Clarification Group | Experimental | Behavioral: Values ClarificationParticipants in this group will receive a values clarification intervention based on Comfort Theory to support emotional awareness, coping, and psychological well-being. |
| Yoga Group | Experimental | Behavioral: YogaA structured yoga intervention delivered over 8 weeks to improve relaxation, emotional regulation, and overall well-being in parents of children with special needs. |
| Control Group | No intervention | –Participants in this group will not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| YogaA 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. | Behavioural | Yoga Group |
| Values ClarificationA 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. | Behavioural | Values Clarification Group |
Primary outcome
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.The Turkish validity and reliability of the General Comfort Scale, developed by Kolcaba in 1992, were established by Kuğuoğlu and Karabacak (2008). The scale is a four-point Likert-type instrument consisting of a total of 48 items. The comfort levels addressed by the scale are relief (16 items), ease (17 items), and transcendence (15 items). The scale comprises both positive and negative items, with the response format arranged in a mixed order. Accordingly, for positive items, a high score (four) indicates a high level of comfort, while a low score (one) indicates a low level of comfort. When scoring the scale, the scores obtained from negative items are reverse-coded and then summed with the scores from positive items. The maximum possible total score is 192, and the minimum is 48. Low comfort is represented by a score of one, and high comfort by a score of four.
1 secondary outcome
Emotional Regulation
Time frame: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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 5 Nov 2026.
- Lee, L. J., Shamburek, R., Son, H., Wallen, G. R., Cox, R., Flynn, S., Yang, L., Bevans, M., Wehrlen, L., \& Ross, A. (2022). Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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 Yoga and Values Clarification in people with Stress and Emotional Regulation, run by Ankara Yildirim Beyazıt 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 7 inclusion and 3 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 5 Nov 2026. 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?
Comfort Level (time frame: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up). 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 5 Nov 2026.