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临床试验/NCT04467229
NCT04467229Unknown不适用

Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Screening questionnaire score

研究概览

简要总结

This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

详细描述

First part : creation of a screening tool. After detailed interviews with chronic pain experts and bibliographic research, a screening tool for mental disorders in chronically painful adolescents has been designed for use by the general practitioner. This tool is composed of 10 questions, making up a score of 10 points. The tool will be compared to two screening tools used in different clinical contexts, the HAD scale and the RPPS scale, in order to determine a positivity threshold. There is only one center participating in the research, the Centre de la Douleur et de la migraine de l'hôpital Trousseau (Trousseau Hospital Pain Center). Parents' consent is required for participation. For this assessment, the adolescents (between 10 and 18 years old) that see a doctor at the Centre de la douleur, will be asked to fill up the questionnaires in the waiting room. The filling of the questionnaire takes a few minutes. At the end of the appointment, the doctor will read the questionnaire to check that all elements have been addressed during the appointment.

Second part : focus group on the questionnaire: 5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.

The data will help designing a guidebook for the clinician explaining the main points in screening for mental disorders in chronic pain adolescent patients.

A validation study for the screening tool will be eventually carried out after the completion of this preliminary study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • patient from 10 to 18 years old
  • chronic pain (existing for more than 3 months or longer than tissue repair time)
  • first consultation in the service
  • Collection of the written consent of the holders of parental authority and agreement of the adolescent
  • Adolescents able to understand the questionnaire and the purpose of the study
  • Affiliation to a social security scheme or beneficiary

排除标准

  • Exclusion Criteria :
  • Decompensated physical or psychological pathology requiring urgent medical treatment
  • Heavy psychological pathology preventing the adolescent's understanding of the study
  • Patient benefiting from State Medical Aid

结局指标

主要结局

Screening questionnaire score

时间窗: Baseline visit

A new Screening questionnaire elaborated beforehand by the study will be answered by patients in order to detect psychological suffering in chronically painful adolescents The screening questionnaire consists in 10 items (yes/no response format)

次要结局

  • Participants feedback(up to 3 months upon recuitment)
  • Hospital Anxiety and Depression (HAD) score(Baseline visit)
  • Pediatric Pain Screening Tool (PPST) score(Baseline visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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