- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hacer DELİBAŞ, Registered Nurse
- Número de teléfono: +90 5514128689
- Correo electrónico: haceeer_91@hotmail.com
Ubicaciones de estudio
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Çorum, Turquía (Türkiye), 19000
- Reclutamiento
- Corum New Indoor Sports Hall
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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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.
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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.
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Sin intervención: Control Group
Participants in this group will not receive any intervention during the study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comfort Level
Periodo de tiempo: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Comfort levels will be measured using a validated scale based on Comfort Theory before and after the intervention.
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Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotional Regulation
Periodo de tiempo: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Changes in emotional regulation levels will be assessed using a validated emotional regulation scale before the intervention and after the 8-week intervention period.
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Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived Stress
Periodo de tiempo: Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Perceived stress levels will be evaluated using a standardized stress scale before and after the 8-week intervention period.
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Baseline; immediately after the 8-week intervention; 1-month follow-up; and 3-month follow-up
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Colaboradores e Investigadores
Patrocinador
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Más información
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Palabras clave
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Otros números de identificación del estudio
- AYBU-SBE-HD-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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