Hand and Upper Limb TraumaISAT-CMMSNCT06918522
Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital
An observational study of Hand and Upper Limb Trauma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand and Upper Limb Trauma
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2025to 9 Apr 2026
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized Rehabilitation Department Pavillon T HEH Hospices Civils of Lyon- hand and upper limb surgery
Who may be able to join
- 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
Who cannot join
- Patients under legal protection
- Any patient who does not have a sufficient command of the language to enable comprehension and expression.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery
Lyon, 69003
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Delta between before and after 16 weeks reduction post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start22 May 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand and Upper Limb TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aram GAZARIAN, Professor, Principal investigator, Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918522
- Sponsor's protocol ID
- 69HCL24_1075
- Acronym
- ISAT-CMMS
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital
- ClinicalTrials.gov ID
- NCT06918522
- Acronym / sponsor ID
- ISAT-CMMS / 69HCL24_1075
- Conditions
- Hand and Upper Limb Trauma
- Keywords
- hand and upper limb trauma, sophrology, art-therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized Rehabilitation Department Pavillon T HEH Hospices Civils of Lyon- hand and upper limb surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under legal protection
- Any patient who does not have a sufficient command of the language to enable comprehension and expression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aram GAZARIAN, Professor principal investigator
Hospices Civils de Lyon. Rehabilitation Department Pavillon T HEH - hand and upper limb surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand and Upper Limb Trauma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Delta between before and after 16 weeks reduction post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.