跳至主要内容
临床试验/NCT06698406
NCT06698406招募中不适用

Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale

Benno Rehberg-Klug1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
incremental validity of the new ABDC scale

研究概览

简要总结

We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire

详细描述

The primary objective is to validate the French version of the PEB scale, called "Echelle d'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".

The hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.

Consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG
  • French-speaking and able to understand the study information
  • ≥18 years of age

排除标准

  • - Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant
  • Enrolment of the investigator, his/her family members, employees and other de-pendent persons

结局指标

主要结局

incremental validity of the new ABDC scale

时间窗: 1 day

Incremental validity is the degree to which a new scale increases the ability to predict an outcome beyond existing parameters and scales. In our case pain self-efficacy, measured by the "pain self-efficacy questionnaire" \[8\], which exists in a validated French version \[9\], is the outcome to be predicted. Hierarchical regression analysis will have four models including in hierarchical order 8 explanatory variables: demographical variables (gender, age, level of education), depressive symptoms and anxiety, pain catastrophizing, pain acceptance, and finally the ABDC scale

次要结局

  • Reliability of the ABDC scale(1 day)
  • Convergent validity(1 day)
  • Discriminant validity(1 day)

研究者

发起方
Benno Rehberg-Klug
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Benno Rehberg-Klug

Clinical professor

University Hospital, Geneva

研究点 (1)

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