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

NCT04467229 | Unknown

• 1 other identifier: APHP200623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Mental Disorder

Keywords

Chronic Pain; Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Screening questionnaire score

  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)

  Baseline visit

Secondary Outcomes (3)

• Hospital Anxiety and Depression (HAD) score

  Baseline visit

• Pediatric Pain Screening Tool (PPST) score

  Baseline visit

• Participants feedback

  up to 3 months upon recuitment

Study Arms (1)

Focus group with chronically painful adolescents

EXPERIMENTAL

Adolescents with chronic pain

Behavioral: Focus group

Interventions

Focus group BEHAVIORAL

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.

Focus group with chronically painful adolescents

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre de la douleur et de la migraine-Hôpital Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Chronic Pain; Mental Disorders

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexandra LOISEL

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra LOISEL, PH

CONTACT

01 71 73 85 47; loisel.alexandra@aphp.fr

Barbara TOURNIAIRE, ph

CONTACT

01 71 73 89 19; barbara.tourniaire@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: July 10, 2020
• Study Start: July 6, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)