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

NCT04711278 | Completed

• 2 other identifiers: APHP2014452019-A03316-51
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus; Surgery

Keywords

hallux valgus; hypnosis; pre-operative anxiety; surgery

Outcome Measures

Primary Outcomes (2)

• Anxiety assessment at baseline

  The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

  baseline, pre-intervention

• Anxiety assessment after the surgery

  The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

  immediately after the surgery

Secondary Outcomes (3)

• Analgesic taken

  at the end of study, an average of 1 day

• Duration of stay

  at the end of study, an average of 1 day

• Pain assessment

  day 1

Study Arms (2)

hypnosis group

EXPERIMENTAL

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

Device: Mask-wearing hypnosis

comparator group

SHAM COMPARATOR

No hypnosis for patients in this arm.

Other: Without hypnosis

Interventions

Mask-wearing hypnosis 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.

hypnosis group

Without hypnosis OTHER

No hypnosis during surgery of Hallux valgus.

comparator group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Location

Related Publications (1)

• 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.

  PMID: 29317347 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christophe MENIGAUX, MD

  Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

  PRINCIPAL INVESTIGATOR

• Marie-Hélène SANDIFORD

  Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 15, 2021
• Study Start: January 7, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: February 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)