- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Çorum, Turkiet (Türkiye), 19000
- Corum New Indoor Sports Hall
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Inget ingripande: Control Group
Participants in this group will not receive any intervention during the study period. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comfort Level
Tidsram: 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. |
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotional Regulation
Tidsram: 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 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. |
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived Stress
Tidsram: 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.The ASÖ-10 questions are scored on a scale of 0 (never) to 4 (very often), with possible scores ranging from 0 to 40. A high score indicates a high level of perceived stress. |
Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
|
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Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AYBU-SBE-HD-01
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