Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner (REPERADO)
Primary Purpose
Chronic Pain, Mental Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Focus group
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Pain focused on measuring Chronic Pain, Mental Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Sites / Locations
- Centre de la douleur et de la migraine-Hôpital Trousseau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Focus group with chronically painful adolescents
Arm Description
Adolescents with chronic pain
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Hospital Anxiety and Depression (HAD) score
Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire
Pediatric Pain Screening Tool (PPST) score
Patients complete a Pediatric Pain Screening Tool questionnaire
Participants feedback
Focus group questions will provide descriptions of patients' experiences with the questionnaire
Full Information
NCT ID
NCT04467229
First Posted
May 25, 2020
Last Updated
July 8, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04467229
Brief Title
Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
Acronym
REPERADO
Official Title
Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Mental Disorder
Keywords
Chronic Pain, Mental Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Focus group with chronically painful adolescents
Arm Type
Experimental
Arm Description
Adolescents with chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Focus group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening questionnaire score
Description
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)
Time Frame
Baseline visit
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression (HAD) score
Description
Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire
Time Frame
Baseline visit
Title
Pediatric Pain Screening Tool (PPST) score
Description
Patients complete a Pediatric Pain Screening Tool questionnaire
Time Frame
Baseline visit
Title
Participants feedback
Description
Focus group questions will provide descriptions of patients' experiences with the questionnaire
Time Frame
up to 3 months upon recuitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra LOISEL, PH
Phone
01 71 73 85 47
Email
loisel.alexandra@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara TOURNIAIRE, ph
Phone
01 71 73 89 19
Email
barbara.tourniaire@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra LOISEL
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de la douleur et de la migraine-Hôpital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra LOISEL, PH
Phone
01 71 73 85 47
Email
loisel.alexandra@aphp.fr
First Name & Middle Initial & Last Name & Degree
Barbara TOURNIAIRE, PH
Phone
01 71 73 89 19
Email
barbara.tourniaire@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
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