Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery (SATISVIR)

Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthopedic
• Intervention / Treatment: Device: Virtual reality

Detailed Description

The study is to compare the patient satisfaction between patients with virtual reality experience and patients without VR experience during the ambulatory orthopedic surgery under local regional anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 388
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Claude PAUCHARD, MD; Phone Number: 33(0)5 36 28 64 00; Email: jc_pauchard@hotmail.com

Study Locations

• France
  • Biarritz, France, 64200
    • RGDS-Clinique Aguiléra
    • Contact: Jean-Claude PAUCHARD, MD; Phone Number: 33 (0)5 36 28 64 00; Email: jc_pauchard@hotmail.com
    • Principal Investigator: Jean-Claude PAUCHARD, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participant who has an ambulatory orthopedic surgery under local regional anesthesia, planned or performed in emergency
• Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.

Exclusion Criteria:

• Participant with visual deficiency or deaf
• Participant who can bear virtual reality
• Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual Reality (VR); Patient with VR experience during the ambulatory orthopedic surgery	Device: Virtual reality; The VR used during the ambulatory orthopedic surgery allows immersive experience in HD-2D virtual environment. Patient can choose among movies, cartoons, entertainments offered for visualization during the surgery
No Intervention: NO VR; Patient without any VR experience during the ambulatory orthopedic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction of operating room management by Net Promoter Score	Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6)	One Day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire	e-SATIS questionnaire : measure of hospitalization experience and patient satisfaction (the best scoring is 100 , excellent satisfaction)	One Day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia experience by EVAN-LR questionnaire	EVAN-LR (Evaluation du Vécu de l'ANesthésie - Local Regionale) questionnaire: five-point Likert scale, defined from 1 to 5 as "much less than expected," "less than expected," "as expected," "more than expected," and "much more than expected." All dimension scores are linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst.	One Day after surgery
Functional outcomes by measurement of symptoms as well as the ability to perform certain activities. (QUICKDASH questionnaire)	Quick DASH( Disabilities of the Arm, Shoulder and Hand) questionnaire : 11 items with 5 response options. Scale scores are calculated ranging from 0 (no disability) to 100 (more severe disability)	One month after surgery

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; Surgery; Virtual Reality; Ambulatory
• Other Study ID Numbers: 2021-A00479-32

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