Chronic Pain
Conditions
Keywords
Pain, Pediatrics, Mindfulness, Adolescents
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.
Interventions
OTHERMindfulness-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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility in France of a mindfulness program : percentage of adolescents who will attend at least 6 of the 8 sessions | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment acceptability | inclusion visit | Rate of eligible adolescents who agreed to participate in the study |
| Attendance rate | 1st session of the program (T1 week) | Percentage of adolescents present at each program session |
| Pain Level | 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. |
| Quality of life at baseline : impact of adolescents health on their everyday life. | 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. |
| Quality of life at the end of program | 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. |
| Quality of life in long term | 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. |
| Chronic pain acceptance | 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. |
| Punctuality at the session | 1st session of the program (T1 week) | binary criterion yes/no |
| Anxiety and Depression | 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. |
| Catastrophism | 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. |
| Mindfulness acceptance | 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. |
| Strengths and Difficulties | 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. |
| Adolescents satisfaction | 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. |
| Parents satisfaction | 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. |
| Functional disability | 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. |
Countries
France
Outcome results
None listed