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

NCT07083180 | Recruiting

• 1 other identifier: 2024-26-MEG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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")

  15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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

Other: Recreative activity

Virtual hypnosis arm

EXPERIMENTAL

patients undergoing medical hypnosis using virtual reality

Other: Medical Hypnosis by virtual reality

Interventions

Recreative activity OTHER

Patients practice a leisure activity before surgery (20 minutes)

Control arm

Medical Hypnosis by virtual reality OTHER

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

Virtual hypnosis arm

Eligibility Criteria

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

You may qualify if:

• First surgery of carpal tunnel

You may not qualify if:

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

Sponsors & Collaborators

• Clinique MEGIVAL: lead

Study Sites (1)

Clinique MEGIVAL

Saint-Aubin-sur-Scie, 76550, France

RECRUITING

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33(0)6 78 27 76 72; mmandon@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)