Carpal Tunnel SurgeryNCT07083180
Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery
A study testing Recreative activity and Medical Hypnosis by virtual reality in people with Carpal Tunnel Surgery, run by Clinique MEGIVAL at 1 site in France.
Trial summary
Anxiety is a predominant factor among patients prior to surgery, particularly in the context of outpatient surgery, where the speed of care and same-day discharge can exacerbate this stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Surgery
- What is being tested?
- Recreative activity and Medical Hypnosis by virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- First surgery of carpal tunnel
Who cannot join
- Patients undergoing treatment for anxiety
- Uncontrolled epilepsy
- Visual (binocular vision) and/or hearing impairments preventing the use of virtual reality
- Pregnancy / breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique MEGIVAL
Saint-Aubin-sur-Scie, 76550
Marion Mandon, PhD, +33(0)6 78 27 76 72, drc@vivalto-sante.com
About this study
Official title: Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery Interventional Study With Minimal Risks and Constraints, Single-center, Prospective
Anxiety is a predominant factor among patients prior to surgery, particularly in the context of outpatient surgery, where the speed of care and same-day discharge can exacerbate this stress. National patient satisfaction surveys, such as e-SATIS CA, show that many patients report significant anxiety before their surgery, which can affect the outcome of the operation and the recovery process. Medical hypnosis has been shown to be an effective way to reduce anxiety in patients before surgery. Indeed, several studies highlight the psychological and physiological benefits of this method for patients who are anxious before minor or major surgery. Hypnosis allows for deep relaxation, helping to better manage the emotions and fears associated with surgery. New technologies, such as virtual reality, are now being integrated into hypnosis practices to improve their effectiveness. Virtual immersion provides distraction and an environment conducive to hypnosis, facilitating induction and further reducing preoperative anxiety. In this context, we wish to conduct a single-center clinical investigation to determine whether the use of the HypnoVR virtual reality headset can help reduce anxiety in patients undergoing outpatient carpal tunnel surgery.
- Conditions
- Carpal Tunnel Surgery
- Being tested
- Recreative activity, Medical Hypnosis by virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreative activityOther
Patients practice a leisure activity before surgery (20 minutes)
Medical Hypnosis by virtual realityOther
Patients benefit from a medical hypnosis session using virtual reality (20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Patients are invited to practice a recreational activity to reduce pre-operative anxiety Receives: Other: Recreative activity |
| Virtual hypnosis arm | Experimental | patients undergoing medical hypnosis using virtual reality Receives: Other: Medical Hypnosis by virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Anxiety level will be measured before and after intervention, using STAI-state Anxiety scale (20 questions with 4 points Likert scale from "not at all" to "totally")
Measured: 15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start8 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique MEGIVAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083180
- Sponsor's protocol ID
- 2024-26-MEG
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery Interventional Study With Minimal Risks and Constraints, Single-center, Prospective
- ClinicalTrials.gov ID
- NCT07083180
- Acronym / sponsor ID
- 2024-26-MEG
- Conditions
- Carpal Tunnel Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique MEGIVALUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Jul 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.
Anxiety is a predominant factor among patients prior to surgery, particularly in the context of outpatient surgery, where the speed of care and same-day discharge can exacerbate this stress. National patient satisfaction surveys, such as e-SATIS CA, show that many patients report significant anxiety before their surgery, which can affect the outcome of the operation and the recovery process. Medical hypnosis has been shown to be an effective way to reduce anxiety in patients before surgery. Indeed, several studies highlight the psychological and physiological benefits of this method for patients who are anxious before minor or major surgery. Hypnosis allows for deep relaxation, helping to better manage the emotions and fears associated with surgery. New technologies, such as virtual reality, are now being integrated into hypnosis practices to improve their effectiveness. Virtual immersion provides distraction and an environment conducive to hypnosis, facilitating induction and further reducing preoperative anxiety. In this context, we wish to conduct a single-center clinical investigation to determine whether the use of the HypnoVR virtual reality headset can help reduce anxiety in patients undergoing outpatient carpal tunnel surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Recreative activityPatients are invited to practice a recreational activity to reduce pre-operative anxiety |
| Virtual hypnosis arm | Experimental | Other: Medical Hypnosis by virtual realitypatients undergoing medical hypnosis using virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First surgery of carpal tunnel
Key exclusion criteria (4 listed)
- Patients undergoing treatment for anxiety
- Uncontrolled epilepsy
- Visual (binocular vision) and/or hearing impairments preventing the use of virtual reality
- Pregnancy / breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recreative activityPatients practice a leisure activity before surgery (20 minutes) | Other | Control arm |
| Medical Hypnosis by virtual realityPatients benefit from a medical hypnosis session using virtual reality (20 minutes) | Other | Virtual hypnosis arm |
Primary outcome
Anxiety level
Time frame: 15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session
Anxiety level will be measured before and after intervention, using STAI-state Anxiety scale (20 questions with 4 points Likert scale from "not at all" to "totally")
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreative activity and Medical Hypnosis by virtual reality in people with Carpal Tunnel Surgery, run by Clinique MEGIVAL 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Mandon, PhD (+33(0)6 78 27 76 72, mmandon@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: 15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session). 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 16 Dec 2025.