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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03338-45 | Other Identifier | ID-RCB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness program | Experimental | To study the feasibility in France of a mindfulness program with mindfulness-based interventions (MBI's) dedicated for adolescents with chronic pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnès SUC, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital des Enfants | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27924146 | Background | Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1. | |
| 26798398 | Background | Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 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) |
| 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 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) |
| 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) |
| 26009534 | Background | 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. |
| 27002445 | Background | 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. |
| 25071620 | Background | 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. |
| 29244734 | Background | 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. |
| 28328699 | Background | 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. |
| 36109288 | Result | 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. |