Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients

Not Applicable

Completed

• Conditions: Surgery; Hallux Valgus
• Interventions: Device: Mask-wearing hypnosis; Other: Without hypnosis

• Registration Number: NCT04711278
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

Detailed Description

As secondary objectives, the study aims

* to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;

* to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Study Timeline

• Study Start: 2021-01-07
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patient ≥ 18 years;
• Autonomous patient living at home;
• Affiliated to a social security scheme;
• Informed consent signed by patient;
• Patient will undergo a planned ambulatory surgery for hallux valgus.

Exclusion Criteria

• Inability to understand STAI-A questionnaire;
• Patient refusal;
• Patient underwent a bilateral surgery;
• Patient judicial decision;
• Covered by french AME health system.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypnosis group	Mask-wearing hypnosis	Mask-wearing as hypnosis method for patients in this arm.
comparator group	Without hypnosis	No hypnosis for patients in this arm.

Primary Outcome Measures

Name	Time	Method
Anxiety assessment at baseline	baseline, pre-intervention	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Anxiety assessment after the surgery	immediately after the surgery	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

Secondary Outcome Measures

Name	Time	Method
Analgesic taken	at the end of study, an average of 1 day	Dose of analgesic taken will be added up.
Duration of stay	at the end of study, an average of 1 day	Duration of stay before discharge of hospital.
Pain assessment	day 1	EVA score, a french auto evaluation tool will be used for pain.

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP; 🇫🇷 Boulogne-Billancourt, France