Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

NCT04905355 | Not Yet Recruiting

• 1 other identifier: 2021-A00479-32
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthopedic

Keywords

Surgery; Virtual Reality; Patient satisfaction; Ambulatory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire

  One Day after surgery

Other Outcomes (2)

• Anesthesia experience by EVAN-LR questionnaire

  One Day after surgery

• Functional outcomes by measurement of symptoms as well as the ability to perform certain activities. (QUICKDASH questionnaire)

  One month after surgery

Study Arms (2)

Virtual Reality (VR)

ACTIVE COMPARATOR

Patient with VR experience during the ambulatory orthopedic surgery

Device: Virtual reality

NO VR

NO INTERVENTION

Patient without any VR experience during the ambulatory orthopedic surgery

Interventions

Virtual reality DEVICE

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

Virtual Reality (VR)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

RGDS-Clinique Aguiléra

Biarritz, 64200, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Jean-Claude PAUCHARD, MD

CONTACT

33(0)5 36 28 64 00; jc_pauchard@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of the main outcome will be not aware of arm attribution
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use of VR or not during the ambulatory orthopedic surgery will be attributed to patient randomly.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)