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Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery

NCT ID: NCT07083180

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control arm

Patients are invited to practice a recreational activity to reduce pre-operative anxiety

Group Type ACTIVE_COMPARATOR

Recreative activity

Intervention Type OTHER

Patients practice a leisure activity before surgery (20 minutes)

Virtual hypnosis arm

patients undergoing medical hypnosis using virtual reality

Group Type EXPERIMENTAL

Medical Hypnosis by virtual reality

Intervention Type OTHER

Patients benefit from a medical hypnosis session using virtual reality (20 minutes)

Interventions

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Recreative activity

Patients practice a leisure activity before surgery (20 minutes)

Intervention Type OTHER

Medical Hypnosis by virtual reality

Patients benefit from a medical hypnosis session using virtual reality (20 minutes)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First surgery of carpal tunnel

Exclusion Criteria

* Patients undergoing treatment for anxiety
* Uncontrolled epilepsy
* Visual (binocular vision) and/or hearing impairments preventing the use of virtual reality
* Pregnancy / breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique MEGIVAL

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique MEGIVAL

Saint-Aubin-sur-Scie, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marion Mandon, PhD

Role: CONTACT

[email protected]
+33(0)6 78 27 76 72

Facility Contacts

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Marion Mandon, PhD

Role: primary

[email protected]
+33(0)6 78 27 76 72

Other Identifiers

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2024-26-MEG

Identifier Type: -

Identifier Source: org_study_id