- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07846514
The Serial Mediating Roles of Pain Acceptance and Pain Self-Efficacy in the Relationship Between Concerns About Pain and Well-Being in Pain Among Individuals With Chronic Pain: A Structural Equation Modeling Study
This study is a cross-sectional, correlational, and analytical study designed to examine the serial mediating roles of pain acceptance and pain self-efficacy in the relationship between pain-related concerns and pain-specific well-being in individuals with chronic pain. Structural equation modeling will be used to simultaneously evaluate the direct and indirect relationships between the variables.
Visão geral do estudo
Status
Condições
Descrição detalhada
It is evident that the experience of chronic pain is not limited to pain intensity alone but is also significantly influenced by an individual's cognitive, emotional, and behavioral responses to pain. In this context, it is important to clarify how pain-related concerns affect an individual's well-being and to identify the mechanisms through which protective psychological processes play a role in this relationship. Accordingly, the aim of this planned study is to examine-using structural equation modeling-the serial mediating roles of pain acceptance and pain self-efficacy in the relationship between pain-related concerns and pain-specific well-being among individuals with chronic pain.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Semanur Bilgiç
- Número de telefone: 05395966328
- E-mail: semanurblgc@gmail.com
Locais de estudo
-
-
Bilecik
-
Bilecik, Bilecik, Turquia (Türkiye), 11000
- Bilecik Seyh Edebali University
-
Contato:
- Semanur Bilgiç
- Número de telefone: 05395966328
- E-mail: semanurblgc@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Having chronic pain that has persisted or recurred for at least three months
Descrição
Inclusion Criteria:
- Individuals aged 18 years and older,
- Having chronic pain that has persisted or recurred for at least three months,
- Being followed up for chronic pain at the Physical Therapy and Rehabilitation Outpatient Clinic,
- Able to read and understand Turkish and communicate at a level sufficient to complete data collection forms,
- And agreeing to participate in the research voluntarily will be included.
Exclusion Criteria:
- Individuals with pain lasting less than three months or experiencing only acute pain,
- Individuals with cancer-related pain,
- Individuals in the palliative or terminal stage,
- Individuals who have undergone major surgery within the last three months and still experience acute/postoperative pain related to the surgery,
- Individuals with cognitive or communication impairments that would prevent them from understanding the research questions and independently responding to the data collection instruments will be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: CROSS_SECTIONAL
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Numerical Rating Scales
Prazo: 1 days
|
Numerical Rating Scales (NRS): In alignment with the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11), participants' pain intensity over the past week, the impact of pain on daily activities, and the level of pain-related distress will be assessed separately using 0-10 numerical rating scales. Pain intensity will be rated from 0 ("no pain") to 10 ("worst pain imaginable"); the impact of pain on daily life from 0 ("no impact") to 10 ("completely prevents my activities"); and pain-related distress from 0 ("no distress") to 10 ("extreme distress"). |
1 days
|
|
University of Washington Pain-Related Worry Scale
Prazo: 1 days
|
University of Washington Pain-Related Worry Scale: This scale was developed to assess individuals' pain-related worries and their levels of pain catastrophizing. The scale consists of a total of 6 items. The items inquire about the individual's thoughts regarding pain over the past seven days and are rated using a five-point Likert-type scale with the options: "Never" (1 point), "Rarely" (2 points), "Occasionally" (3 points), "Often" (4 points), and "Always" (5 points). Total scores on the scale range from 6 to 30. There are no reverse-scored items or established cut-off points for the scale. A higher total score indicates increased pain-related worry and a higher level of pain catastrophizing. When necessary, the raw total score can be converted to a T-score using the scale's conversion table. In the study regarding the Turkish validity and reliability of the scale, the Cronbach's alpha value was reported as 0.85. |
1 days
|
|
Chronic Pain Acceptance Questionnaire-Short Form
Prazo: 1 days
|
Chronic Pain Acceptance Questionnaire-Short Form: The scale assesses an individual's level of acceptance regarding the pain experience and their ability to maintain daily life in the presence of pain, shifting away from the constant struggle to control or eliminate it. The scale consists of 8 items and encompasses the dimensions of activity engagement and pain willingness/acceptance. The Turkish validity and reliability study of the scale was conducted by Zure et al. in 2022. Cronbach's alpha values for the scale were found to be 0.76 and 0.80, respectively. The scale utilizes a six-point Likert-type format, with scores ranging from 0 to 48. Higher scores indicate that the patient has a greater acceptance of the pain and copes with it more effectively. |
1 days
|
|
The University of Washington Pain-Related Self-Efficacy Scale-Short Form
Prazo: 1 days
|
The University of Washington Pain-Related Self-Efficacy Scale-Short Form is a 6-item scale developed to assess patients' perceptions regarding their self-efficacy-or confidence-in performing daily, social, and personal activities despite pain. Each item is rated on a 5-point Likert-type scale ranging from 1 ("not at all confident") to 5 ("completely confident"). Total scores on the scale range from 6 to 30, with higher scores indicating a higher level of pain-related self-efficacy. The Cronbach's alpha value was reported as 0.87 in the study regarding the Turkish validity and reliability of the scale. |
1 days
|
|
Well-Being in Pain Questionnaire
Prazo: 1 days
|
This scale was developed to assess well-being in the presence of pain among individuals with chronic pain, as well as the psychological, social, and lifestyle-related characteristics that support such well-being. The scale consists of a total of 11 items rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("almost always"). The total score is calculated by summing the responses to all items and ranges from 0 to 44. Higher scores indicate a higher level of pain-related well-being; a score of 0 represents the minimum level, while a score of 44 represents the maximum level of pain-related well-being. In the study regarding the Turkish validity and reliability of the scale, the Cronbach's alpha value was reported as 0.713. |
1 days
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- Kronik Ağrılı Bireyler-1
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .