- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hacer DELİBAŞ, Registered Nurse
- Número de telefone: +90 5514128689
- E-mail: haceeer_91@hotmail.com
Locais de estudo
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Çorum, Turquia (Türkiye), 19000
- Recrutamento
- Corum New Indoor Sports Hall
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: Control Group
Participants in this group will not receive any intervention during the study period.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comfort Level
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Emotional Regulation
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Perceived Stress
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AYBU-SBE-HD-01
Plano para dados de participantes individuais (IPD)
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