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RecruitingNCT07083180Updated Dec 16, 2025

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

An interventional study of Recreative activity and Medical Hypnosis by virtual reality in Carpal Tunnel Surgery, sponsored by Clinique MEGIVAL. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Clinique MEGIVAL · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carpal Tunnel Surgery
03

In context

Lead sponsor

Clinique MEGIVAL is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • First surgery of carpal tunnel

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Control arm

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

    Other: Recreative activity

  • Experimental
    Virtual hypnosis arm

    patients undergoing medical hypnosis using virtual reality

    Other: Medical Hypnosis by virtual reality

Interventions

  • OtherRecreative activity

    Patients practice a leisure activity before surgery (20 minutes)

  • OtherMedical Hypnosis by virtual reality

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

06

What researchers measure

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")

    Time frame: 15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session

07

Study locations

1 of 1 sites recruiting
  • Clinique MEGIVAL
    Saint-Aubin-sur-Scie, 76550, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07083180
Lead sponsor
Clinique MEGIVAL
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Dec 8, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Dec 16, 2025

Study contacts

Marion Mandon, PhD
Contact
mmandon@vivalto-sante.com
+33(0)6 78 27 76 72

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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