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

NCT ID: NCT04711278

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2022-05-17

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.

Conditions

Hallux Valgus; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hypnosis group

Mask-wearing as hypnosis method for patients in this arm.

Group Type: EXPERIMENTAL

Mask-wearing hypnosis

Intervention Type: DEVICE

Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis.

Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient.

comparator group

No hypnosis for patients in this arm.

Group Type: SHAM_COMPARATOR

Without hypnosis

Intervention Type: OTHER

No hypnosis during surgery of Hallux valgus.

Interventions

Mask-wearing hypnosis

Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis.

Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient.

Intervention Type: DEVICE

Without hypnosis

No hypnosis during surgery of Hallux valgus.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe MENIGAUX, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Marie-Hélène SANDIFORD

Role: STUDY_DIRECTOR

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Locations

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Boulogne-Billancourt, , France

Countries

France

References

Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.

Reference Type: BACKGROUND

PMID: 29317347 (View on PubMed)

Other Identifiers

2019-A03316-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP201445

Identifier Type: -

Identifier Source: org_study_id