Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients (PACAH-UCA HV)

Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality

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

Study Overview

• Status: Completed
• Conditions: Surgery; Hallux Valgus
• Intervention / Treatment: Device: Mask-wearing hypnosis; Other: Without hypnosis

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe MENIGAUX, MD; Phone Number: + 33 (0)1 49 09 54 30; Email: christophe.ménigaux@aphp.fr
• Study Contact Backup: Name: Marie-Hélène SANDIFORD; Phone Number: + 33 (0)1 49 09 59 30; Email: mh.sandiford@gmail.com

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypnosis group; Mask-wearing as hypnosis method for patients in this arm.	Device: 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.
Sham Comparator: comparator group; No hypnosis for patients in this arm.	Other: Without hypnosis; No hypnosis during surgery of Hallux valgus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christophe MENIGAUX, MD, Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP; Study Director: Marie-Hélène SANDIFORD, Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: surgery; hypnosis; hallux valgus; pre-operative anxiety
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: APHP201445; 2019-A03316-51 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No