Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

Orthopedic Clinical Trial

— SATISVIR  

Official title:

Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04905355
• Other study ID #: 2021-A00479-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Jean-Claude PAUCHARD, MD
• Phone: 33(0)5 36 28 64 00
• Email: jc_pauchard[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 388
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopedic

Intervention

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

Locations

Country	Name	City	State
France	RGDS-Clinique Aguiléra	Biarritz

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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