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Completed

NCT Number: NCT03561077

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

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

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital des Enfants

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based interventions (MBI's)

Other

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 outcomes

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

    Time frame: End of the mindfulness program (8 weeks)

    The primary outcome will be the percentage of adolescents who will attend at least 6 of the 8 sessions.

Secondary outcomes

  1. Attendance rate

    Time frame: 1st session of the program (T1 week)

    Percentage of adolescents present at each program session

  2. Attendance rate

    Time frame: 2nd session of the program (T2 weeks)

    Percentage of adolescents present at each program session

  3. Attendance rate

    Time frame: 3rd session of the program (T3 weeks)

    Percentage of adolescents present at each program session

  4. Attendance rate

    Time frame: 4th session of the program (T4 weeks)

    Percentage of adolescents present at each program session

  5. Attendance rate

    Time frame: 5th session of the program (T5 weeks)

    Percentage of adolescents present at each program session

  6. Attendance rate

    Time frame: 6th session of the program (T6 weeks)

    Percentage of adolescents present at each program session

  7. Attendance rate

    Time frame: 7th session of the program (T7 weeks)

    Percentage of adolescents present at each program session

  8. Attendance rate

    Time frame: 8th session of the program (T8 weeks)

    Percentage of adolescents present at each program session

  9. Punctuality at the session

    Time frame: 1st session of the program (T1 week)

    binary criterion yes/no

  10. Punctuality at the session

    Time frame: 2nd session of the program (T2 weeks)

    binary criterion yes/no

  11. Punctuality at the session

    Time frame: 3rd session of the program (T3 weeks)

    binary criterion yes/no

  12. Punctuality at the session

    Time frame: 4th session of the program (T4 weeks)

    binary criterion yes/no

  13. Punctuality at the session

    Time frame: 5th session of the program (T5 weeks)

    binary criterion yes/no

  14. Punctuality at the session

    Time frame: 6th session of the program (T6 weeks)

    binary criterion yes/no

  15. Punctuality at the session

    Time frame: 7th session of the program (T7 weeks)

    binary criterion yes/no

  16. Punctuality at the session

    Time frame: 8th session of the program (T8 weeks)

    binary criterion yes/no

  17. Treatment acceptability

    Time frame: inclusion visit

    Rate of eligible adolescents who agreed to participate in the study

  18. Treatment acceptability

    Time frame: 2nd session of the program (T2 weeks)

    Daily practice at home (binary criterion yes/no)

  19. Treatment acceptability

    Time frame: 3rd session of the program (T3 weeks)

    Daily practice at home (binary criterion yes/no)

  20. Treatment acceptability

    Time frame: 4th session of the program (T4 weeks)

    Daily practice at home (binary criterion yes/no)

  21. Treatment acceptability

    Time frame: 5th session of the program (T5 weeks)

    Daily practice at home (binary criterion yes/no)

  22. Treatment acceptability

    Time frame: 6th session of the program (T6 weeks)

    Daily practice at home (binary criterion yes/no)

  23. Treatment acceptability

    Time frame: 7th session of the program (T7 weeks)

    Daily practice at home (binary criterion yes/no)

  24. Treatment acceptability

    Time frame: 8th session of the program (T8 weeks)

    Daily practice at home (binary criterion yes/no)

  25. Pain Level

    Time frame: Inclusion visit (baseline)

    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.

  26. Pain Level

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  27. Pain Level

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  28. Quality of life at baseline : impact of adolescents health on their everyday life.

    Time frame: Inclusion visit (baseline)

    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.

  29. Quality of life at the end of program

    Time frame: T2 Visit (1 week after the end of the 8-week 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.

  30. Quality of life in long term

    Time frame: T3 Visit (3 months after the end of the 8-week 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.

  31. Chronic pain acceptance

    Time frame: Inclusion visit (baseline)

    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.

  32. Chronic pain acceptance

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  33. Chronic pain acceptance

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  34. Functional disability

    Time frame: Inclusion visit (baseline)

    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.

  35. Functional disability

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  36. Functional disability

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  37. Anxiety and Depression

    Time frame: Inclusion visit (baseline)

    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.

  38. Anxiety and Depression

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  39. Anxiety and Depression

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  40. Catastrophism

    Time frame: Inclusion visit (baseline)

    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.

  41. Catastrophism

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  42. Catastrophism

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  43. Mindfulness acceptance

    Time frame: Inclusion visit (baseline)

    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.

  44. Mindfulness acceptance

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  45. Mindfulness acceptance

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  46. Strengths and Difficulties

    Time frame: Inclusion visit (baseline)

    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.

  47. Strengths and Difficulties

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  48. Strengths and Difficulties

    Time frame: T3 Visit (3 months after the end of the 8-week program)

    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.

  49. Adolescents satisfaction

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    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.

  50. Parents satisfaction

    Time frame: T2 Visit (1 week after the end of the 8-week program)

    Parents satisfaction about the mindfulness program followed by their children will be assessed using a satisfaction questionnaire with 8 items designed for the study.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PEACEFULL

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2018
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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