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

Primary Purpose

Hallux Valgus, Surgery

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Mask-wearing hypnosis

Without hypnosis

About this trial

This is an interventional prevention trial for Hallux Valgus focused on measuring hallux valgus, hypnosis, pre-operative anxiety, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

hypnosis group

comparator group

Arm Description

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

No hypnosis for patients in this arm.

Outcomes

Primary Outcome Measures

Anxiety assessment at baseline

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

Anxiety assessment after the surgery

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

Secondary Outcome Measures

Analgesic taken

Dose of analgesic taken will be added up.

Duration of stay

Duration of stay before discharge of hospital.

Pain assessment

EVA score, a french auto evaluation tool will be used for pain.

Full Information

NCT ID

NCT04711278

First Posted

January 7, 2021

Last Updated

February 28, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04711278

Brief Title

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

Acronym

PACAH-UCA HV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 7, 2021 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hallux Valgus, Surgery

Keywords

hallux valgus, hypnosis, pre-operative anxiety, surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hypnosis group

Arm Type

Experimental

Arm Description

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

Arm Title

comparator group

Arm Type

Sham Comparator

Arm Description

No hypnosis for patients in this arm.

Intervention Type

Device

Intervention Name(s)

Mask-wearing hypnosis

Intervention Description

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

Other

Intervention Name(s)

Without hypnosis

Intervention Description

No hypnosis during surgery of Hallux valgus.

Primary Outcome Measure Information:

Title

Anxiety assessment at baseline

Description

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

Time Frame

baseline, pre-intervention

Title

Anxiety assessment after the surgery

Description

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

Time Frame

immediately after the surgery

Secondary Outcome Measure Information:

Title

Analgesic taken

Description

Dose of analgesic taken will be added up.

Time Frame

at the end of study, an average of 1 day

Title

Duration of stay

Description

Duration of stay before discharge of hospital.

Time Frame

at the end of study, an average of 1 day

Title

Pain assessment

Description

EVA score, a french auto evaluation tool will be used for pain.

Time Frame

day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christophe MENIGAUX, MD

Phone

+ 33 (0)1 49 09 54 30

christophe.ménigaux@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Hélène SANDIFORD

Phone

+ 33 (0)1 49 09 59 30

mh.sandiford@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe MENIGAUX, MD

Organizational Affiliation

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marie-Hélène SANDIFORD

Organizational Affiliation

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Official's Role

Study Director

Facility Information:

Facility Name

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

City

Boulogne-Billancourt

ZIP/Postal Code

92100

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29317347

Citation

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.

Results Reference

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

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