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

NCT03561077 | Completed

• 2 other identifiers: RC31/17/03542017-A03338-45
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Keywords

Pain; Pediatrics; Mindfulness; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (50)

• Attendance rate

  1st session of the program (T1 week)

• Attendance rate

  2nd session of the program (T2 weeks)

• Attendance rate

  3rd session of the program (T3 weeks)

• Attendance rate

  4th session of the program (T4 weeks)

• Attendance rate

  5th session of the program (T5 weeks)

Study Arms (1)

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.

Other: Mindfulness-based interventions (MBI's)

Interventions

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.

Mindfulness program

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• intellectual deficit not allowing to participate in a meditation program
• participating in research involving body therapies

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital des Enfants

Toulouse, 31059, France

Location

Related Publications (8)

• 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.

  PMID: 5130089 BACKGROUND

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

  PMID: 4700163 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.

  PMID: 26009534 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.

  PMID: 27002445 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.

  PMID: 25071620 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.

  PMID: 29244734 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.

  PMID: 28328699 BACKGROUND

• 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.

  PMID: 36109288 RESULT

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agnès SUC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 19, 2018
• Study Start: May 2, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)