Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital (ISAT-CCMS)

June 20, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Delta between before and after 16 weeks reduction post surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Aram GAZARIAN, Professor, Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 22, 2026

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL24_1075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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