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Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain (PEACEFULL)

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness-based interventions (MBI's)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring Pain, Pediatrics, Mindfulness, Adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Teenagers from 12 to 17 years of age followed at the Children's Hospital of Toulouse, as part of the Multidisciplinary Consultation of Pain
  • including French.
  • With the consent of the teenager and the parents
  • Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

  • intellectual deficit not allowing to participate in a meditation program
  • participating in research involving body therapies

Sites / Locations

  • Hôpital des EnfantsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness program

Arm Description

To study the feasibility in France of a mindfulness program with mindfulness-based interventions (MBI's) dedicated for adolescents with chronic pain.

Outcomes

Primary Outcome Measures

Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions
The primary outcome will be the percentage of adolescents who will attend at least 6 of the 8 sessions.

Secondary Outcome Measures

Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Attendance rate
Percentage of adolescents present at each program session
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Punctuality at the session
binary criterion yes/no
Treatment acceptability
Rate of eligible adolescents who agreed to participate in the study
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Treatment acceptability
Daily practice at home (binary criterion yes/no)
Pain Level
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Pain Level
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Pain Level
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Quality of life at baseline : impact of adolescents health on their everyday life.
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Quality of life at the end of program
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Quality of life in long term
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Chronic pain acceptance
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Chronic pain acceptance
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Chronic pain acceptance
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Functional disability
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Functional disability
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Functional disability
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Anxiety and Depression
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Anxiety and Depression
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Anxiety and Depression
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Catastrophism
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Catastrophism
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Catastrophism
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Mindfulness acceptance
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Mindfulness acceptance
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Mindfulness acceptance
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Strengths and Difficulties
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Strengths and Difficulties
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Strengths and Difficulties
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Adolescents satisfaction
Adolescents satisfaction about the mindfulness program will be assessed using a satisfaction questionnaire with 8 items designed for this study. For each item, the modality answers are scored from 1 to 4.
Parents satisfaction
Parents satisfaction about the mindfulness program followed by their children will be assessed using a satisfaction questionnaire with 8 items designed for the study.

Full Information

First Posted
April 27, 2018
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03561077
Brief Title
Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain
Acronym
PEACEFULL
Official Title
Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

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
The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness
Detailed Description
Paediatric chronic pain can lead to serious consequences in terms of daily functioning (school absenteeism and loss of social interactions) and global quality of life. Mindfulness-based interventions (MBI's) approaches which emphasize acceptance rather than control of pain have gained increasing attention in adults with chronic pain. The effectiveness of MBI's for chronic pain in paediatric population remains largely unknown. An MBI program for adolescent was conducted in Toronto's Hospital for Sick Children and happened to be feasible and well received for adolescents with chronic pain conditions. The aim of the present program is to study the feasibility in France of a mindfulness program dedicated for adolescents with chronic pain. An eight-session, two hour Mindfulness Based Intervention dedicated to adolescents will be provided. The intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. Topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Pain, Pediatrics, Mindfulness, Adolescents

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness program
Arm Type
Experimental
Arm Description
To study the feasibility in France of a mindfulness program with mindfulness-based interventions (MBI's) dedicated for adolescents with chronic pain.
Intervention Type
Other
Intervention Name(s)
Mindfulness-based interventions (MBI's)
Intervention Description
Mindfulness Based Intervention with eight sessions (one session per week) of two hours dedicated to adolescents will be provided. The intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. Topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.
Primary Outcome Measure Information:
Title
Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions
Description
The primary outcome will be the percentage of adolescents who will attend at least 6 of the 8 sessions.
Time Frame
End of the mindfulness program (8 weeks)
Secondary Outcome Measure Information:
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
1st session of the program (T1 week)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
2nd session of the program (T2 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
3rd session of the program (T3 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
4th session of the program (T4 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
5th session of the program (T5 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
6th session of the program (T6 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
7th session of the program (T7 weeks)
Title
Attendance rate
Description
Percentage of adolescents present at each program session
Time Frame
8th session of the program (T8 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
1st session of the program (T1 week)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
2nd session of the program (T2 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
3rd session of the program (T3 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
4th session of the program (T4 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
5th session of the program (T5 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
6th session of the program (T6 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
7th session of the program (T7 weeks)
Title
Punctuality at the session
Description
binary criterion yes/no
Time Frame
8th session of the program (T8 weeks)
Title
Treatment acceptability
Description
Rate of eligible adolescents who agreed to participate in the study
Time Frame
inclusion visit
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
2nd session of the program (T2 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
3rd session of the program (T3 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
4th session of the program (T4 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
5th session of the program (T5 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
6th session of the program (T6 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
7th session of the program (T7 weeks)
Title
Treatment acceptability
Description
Daily practice at home (binary criterion yes/no)
Time Frame
8th session of the program (T8 weeks)
Title
Pain Level
Description
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Time Frame
Inclusion visit (baseline)
Title
Pain Level
Description
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Pain Level
Description
Pain level will be assessed using Visual Analog Scale (from 0 "no pain" to 10 "the worst pain possible "). The pain will be measured by the average of the visual analogue rating scales evaluated over the last 8 days.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Quality of life at baseline : impact of adolescents health on their everyday life.
Description
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Time Frame
Inclusion visit (baseline)
Title
Quality of life at the end of program
Description
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Quality of life in long term
Description
Quality of life will be assessed using the french scale VSPA-12 ("Vécu et Santé Perçue de l'adolescent - 12 items", "Lived and Health Perceived in 12 items) which is a self-questionnaire to assess the impact of adolescents health on their everyday life. The 12 items have five possible answers: never, rarely, sometimes, often, always.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Chronic pain acceptance
Description
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Time Frame
Inclusion visit (baseline)
Title
Chronic pain acceptance
Description
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Chronic pain acceptance
Description
Chronic pain acceptance will be assessed using CPAQ-A (Chronic Pain Acceptance Questionnaire, Adolescent version) translated in French. CPAQ-A (Questionnaire for acceptance of chronic pain for adolescents) has 20 items For each item, the answer modalities are: 0= Never True, 1 = Rarely true, 2 = sometimes true, 3 = Often true, 4 = always true.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Functional disability
Description
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Time Frame
Inclusion visit (baseline)
Title
Functional disability
Description
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Functional disability
Description
Functional disability will be assessed using FDI (Functional Disability Inventory) which is a functional disability scale to assess physical problems or any difficulties that adolescents may have in performing activities of daily living. FDI have 15 items. For each item, the answer modalities are 0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble and 4 = impossible. The total FDI score is a sum of all of the items. The FDI score ranges from 0 to 60, with higher score indicating greater functional disability.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Anxiety and Depression
Description
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Time Frame
Inclusion visit (baseline)
Title
Anxiety and Depression
Description
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Anxiety and Depression
Description
The anxiety and depression will be assessed using the french version of the Revised Children's Anxiety and Depression Scale (RCADS) intended to evaluate the symptomatology associated with anxiety disorders and major depression in children. This scale have 29 items. For each item, the possible answers are: never, sometimes, often, always.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Catastrophism
Description
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Time Frame
Inclusion visit (baseline)
Title
Catastrophism
Description
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Catastrophism
Description
Catastrophism will be assessed using PCS-Ado (Pain Catastrophizing Scale for Francophone Adolescents) which identifies the thoughts and emotions that may be associated with the pain. PCS-Ado have 13 items. For each item, the possible answers are: never, rarely, sometimes, often and always.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Mindfulness acceptance
Description
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Time Frame
Inclusion visit (baseline)
Title
Mindfulness acceptance
Description
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Mindfulness acceptance
Description
Mindfulness acceptance will be assessed using the French version of Five Facets Mindfulness Questionnaire (FFMQ) with 39 items. For each item the possible answers are: 1 = never or very rarely true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often or always true.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Strengths and Difficulties
Description
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Time Frame
Inclusion visit (baseline)
Title
Strengths and Difficulties
Description
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Strengths and Difficulties
Description
Strengths and difficulties will be assessed using the french version of the Strengths and Difficulties Questionnaire (SDQ-Fra) with 25 items. For each item, the possible answers are : not true, a little true, very true. The total difficulty score of the SDQ ranges from 0-40.
Time Frame
T3 Visit (3 months after the end of the 8-week program)
Title
Adolescents satisfaction
Description
Adolescents satisfaction about the mindfulness program will be assessed using a satisfaction questionnaire with 8 items designed for this study. For each item, the modality answers are scored from 1 to 4.
Time Frame
T2 Visit (1 week after the end of the 8-week program)
Title
Parents satisfaction
Description
Parents satisfaction about the mindfulness program followed by their children will be assessed using a satisfaction questionnaire with 8 items designed for the study.
Time Frame
T2 Visit (1 week after the end of the 8-week program)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Teenagers from 12 to 17 years of age followed at the Children's Hospital of Toulouse, as part of the Multidisciplinary Consultation of Pain including French. With the consent of the teenager and the parents Affiliated person or beneficiary of a social security scheme. Exclusion Criteria: intellectual deficit not allowing to participate in a meditation program participating in research involving body therapies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès SUC, MD
Phone
5 34 55 86 61
Ext
33
Email
suc.a@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie IANUZZI, PhD
Email
IANNUZZI.S@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès SUC, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès SUC, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26009534
Citation
Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297.
Results Reference
background
PubMed Identifier
27002445
Citation
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Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

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