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

NCT ID: NCT03561077

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2021-03-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mindfulness program

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

Group Type: EXPERIMENTAL

Mindfulness-based interventions (MBI's)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnès SUC, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Hôpital des Enfants

Toulouse, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 5130089 (View on PubMed)

Simecek O, Kralik J. [Ethical justification of hemicorporectomy]. Rozhl Chir. 1973 Apr;52(4):240-3. No abstract available. Czech.

Reference Type: BACKGROUND

PMID: 4700163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26009534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27002445 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25071620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29244734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28328699 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36109288 (View on PubMed)

Other Identifiers

2017-A03338-45

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0354

Identifier Type: -

Identifier Source: org_study_id