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NCT Number: NCT04905355

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.

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Key information

Conditions

Orthopedic Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RGDS-Clinique Aguiléra

Biarritz, 64200, France

Location contact

Jean-Claude PAUCHARD, MD

CONTACT

[email protected]

33 (0)5 36 28 64 00

Jean-Claude PAUCHARD, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Patient satisfaction of operating room management by Net Promoter Score

    Time frame: One Day after surgery

    Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6)

Secondary outcomes

  1. Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire

    Time frame: One Day after surgery

    e-SATIS questionnaire : measure of hospitalization experience and patient satisfaction (the best scoring is 100 , excellent satisfaction)

Other outcomes

  1. Anesthesia experience by EVAN-LR questionnaire

    Time frame: One Day after surgery

    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.

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

    Time frame: One month after surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Claude PAUCHARD, MD

CONTACT

[email protected]

33(0)5 36 28 64 00

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

Acronym: SATISVIR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 27, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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