Chronic PainREPERADONCT04467229
Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
A study testing Focus group in people with Chronic Pain and Mental Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Chronic Pain, Mental Disorder
- What is being tested?
- Focus group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de la douleur et de la migraine-Hôpital Trousseau
Paris, 75012
Alexandra LOISEL, PH, 01 71 73 85 47, loisel.alexandra@aphp.fr
Barbara TOURNIAIRE, PH, 01 71 73 89 19, barbara.tourniaire@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Mental Disorder
- Being tested
- Focus group
- Keywords
- Chronic Pain, Mental Disorders
- Medical subject headings
- Chronic Pain, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Focus group with chronically painful adolescents | Experimental | Adolescents with chronic pain Receives: Behavioral: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline visit
Secondary outcomes (3)
Hospital Anxiety and Depression (HAD) score
Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire
Measured: Baseline visit
Pediatric Pain Screening Tool (PPST) score
Patients complete a Pediatric Pain Screening Tool questionnaire
Measured: Baseline visit
Participants feedback
Focus group questions will provide descriptions of patients' experiences with the questionnaire
Measured: up to 3 months upon recuitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start6 Jul 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra LOISEL, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467229
- Sponsor's protocol ID
- APHP200623
- Acronym
- REPERADO
- Status last verified
- Jul 2020
- First submitted
- 25 May 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
- ClinicalTrials.gov ID
- NCT04467229
- Acronym / sponsor ID
- REPERADO / APHP200623
- Conditions
- Chronic Pain, Mental Disorder
- Keywords
- Chronic Pain, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Jul 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus group with chronically painful adolescents | Experimental | Behavioral: Focus groupAdolescents with chronic pain |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group5 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. | Behavioural | Focus group with chronically painful adolescents |
Primary outcome
Screening questionnaire score
Time frame: 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)
3 secondary outcomes
Hospital Anxiety and Depression (HAD) score
Time frame: Baseline visit
Pediatric Pain Screening Tool (PPST) score
Time frame: Baseline visit
Participants feedback
Time frame: up to 3 months upon recuitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra LOISEL principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus group in people with Chronic Pain and Mental Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra LOISEL, PH (01 71 73 85 47, loisel.alexandra@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening questionnaire score (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.