Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital

NCT06918522 | Recruiting

• 1 other identifier: 69HCL24_1075
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The human and economic impact of hand and upper limb pathologies, whether acute or chronic, surgical or medical, is considerable on a national level. Hand wounds and traumas account for 1/3 of work-related accidents and their consequences. The surgical procedure and its technical quality are essential, but so is the re-education and rehabilitation phase. It is in this post-operative context that sophrology and art therapy could have their place. Literature in this precise field is non-existent. A study is therefore needed to determine the quality of life, feasibility and acceptability of these new techniques in the rehabilitation department of the Édouard Herriot Hospital's Hand and Upper Limb Surgery Unit. Sophrology and art therapy could help to limit upper-limb sequelae by promoting confidence-building and functional participation, thus helping patients to return more quickly to an active life. Given the current state of knowledge, the hypothesis being tested is that, within the framework of an existing multi-disciplinary team, art therapy and sophrology could improve quality of life and find favorable adherence on the part of patients usually cared for in the upper limb surgery department.

Conditions

Hand and Upper Limb Trauma

Keywords

hand and upper limb trauma; sophrology; art-therapy

Outcome Measures

Primary Outcomes (1)

• Quality of life

  The outcome measure of quality of life will be estimated by the SF12 score (Short-form 12 health survey) in its physical (pain) and mental (anxiety) dimensions.

  Delta between before and after 16 weeks reduction post surgery

Study Arms (1)

Art-therapy and sophrology evaluation

Each patient eligible for the study will, additionally to the standard care have repeated sessions of sophrology and/or art-therapy along the re-education process. Quality of life as well as anxiety, pain will be assessed before and after each session and at the begining and the end of the re-education process

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized Rehabilitation Department Pavillon T HEH Hospices Civils of Lyon- hand and upper limb surgery

You may qualify if:

• Adult (aged ≥ 18 years)
• Men and women
• Cared for in the hand and upper limb surgery department as part of emergency or scheduled activity or rehabilitation.
• Wishing to benefit from sophrology and/or art therapy in their care pathway.
• Having expressed his non-opposition

You may not qualify if:

• Patients under legal protection
• Any patient who does not have a sufficient command of the language to enable comprehension and expression.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery

Lyon, 69003, France

RECRUITING

Study Officials

• Aram GAZARIAN, Professor

  Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aram GAZARIAN, Professor

CONTACT

+33 4 72 11 13 00; aram.gazarian@chu-lyon.fr

Julien BERTHILLER

CONTACT

+33 4 27 85 63 01; julien.berthiller@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: April 9, 2025
• Study Start: May 22, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 22, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (1)