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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Mindfulness-based interventions (MBI's)

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Hopital des Enfants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Mindfulness-based interventions (MBI's); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of the mindfulness program (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance rate	Percentage of adolescents present at each program session	1st session of the program (T1 week)
Attendance rate	Percentage of adolescents present at each program session	2nd session of the program (T2 weeks)
Attendance rate	Percentage of adolescents present at each program session	3rd session of the program (T3 weeks)
Attendance rate	Percentage of adolescents present at each program session	4th session of the program (T4 weeks)
Attendance rate	Percentage of adolescents present at each program session	5th session of the program (T5 weeks)
Attendance rate	Percentage of adolescents present at each program session	6th session of the program (T6 weeks)
Attendance rate	Percentage of adolescents present at each program session	7th session of the program (T7 weeks)
Attendance rate	Percentage of adolescents present at each program session	8th session of the program (T8 weeks)
Punctuality at the session	binary criterion yes/no	1st session of the program (T1 week)
Punctuality at the session	binary criterion yes/no	2nd session of the program (T2 weeks)
Punctuality at the session	binary criterion yes/no	3rd session of the program (T3 weeks)
Punctuality at the session	binary criterion yes/no	4th session of the program (T4 weeks)
Punctuality at the session	binary criterion yes/no	5th session of the program (T5 weeks)
Punctuality at the session	binary criterion yes/no	6th session of the program (T6 weeks)
Punctuality at the session	binary criterion yes/no	7th session of the program (T7 weeks)
Punctuality at the session	binary criterion yes/no	8th session of the program (T8 weeks)
Treatment acceptability	Rate of eligible adolescents who agreed to participate in the study	inclusion visit
Treatment acceptability	Daily practice at home (binary criterion yes/no)	2nd session of the program (T2 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	3rd session of the program (T3 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	4th session of the program (T4 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	5th session of the program (T5 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	6th session of the program (T6 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	7th session of the program (T7 weeks)
Treatment acceptability	Daily practice at home (binary criterion yes/no)	8th session of the program (T8 weeks)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	Inclusion visit (baseline)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T3 Visit (3 months after the end of the 8-week program)
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.	T2 Visit (1 week after the end of the 8-week program)
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.	T2 Visit (1 week after the end of the 8-week program)
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 (VSPA) - 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.	Inclusion visit (baseline)
Chronic pain acceptance	Chronic pain acceptance will be assessed using Chronic Pain Acceptance Questionnaire, Adolescent version (CPAQ-A) translated in French. CPAQ-A 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.	Inclusion visit (baseline)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Agnès SUC, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
• 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.
• Zenner C, Herrnleben-Kurz S, Walach H. Mindfulness-based interventions in schools-a systematic review and meta-analysis. Front Psychol. 2014 Jun 30;5:603. doi: 10.3389/fpsyg.2014.00603. eCollection 2014.
• Ruskin D, Harris L, Stinson J, Kohut SA, Walker K, McCarthy E. "I Learned to Let Go of My Pain". The Effects of Mindfulness Meditation on Adolescents with Chronic Pain: An Analysis of Participants' Treatment Experience. Children (Basel). 2017 Dec 15;4(12):110. doi: 10.3390/children4120110.
• Ruskin DA, Gagnon MM, Kohut SA, Stinson JN, Walker KS. A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Clin J Pain. 2017 Nov;33(11):1019-1029. doi: 10.1097/AJP.0000000000000490.
• Gray AR, Roberts CJ. The stability of resistance to diminazene aceturate and quihapyramine sulphate in a strain of Trypanosoma vivax during cyclical transmission through antelope. Parasitology. 1971 Aug;63(1):163-8. doi: 10.1017/s0031182000067512. No abstract available.
• Simecek O, Kralik J. [Ethical justification of hemicorporectomy]. Rozhl Chir. 1973 Apr;52(4):240-3. No abstract available. Czech.
• Suc A, Cayzac D, Iannuzzi S, Garnier C, Bonneau B, Sommet A. Peacefull: A French mindfulness-based intervention for adolescents with chronic pain a feasibility study. Arch Pediatr. 2022 Nov;29(8):581-587. doi: 10.1016/j.arcped.2022.06.006. Epub 2022 Sep 13.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimated): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Pain; Mindfulness; Pediatrics
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain
• Other Study ID Numbers: RC31/17/0354; 2017-A03338-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No