Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change

Last updated: November 27, 2023
Sponsor: University of Lausanne Hospitals
Overall Status: Completed

Phase

N/A

Condition

Pain

Anxiety Disorders

Panic Disorders

Treatment

VRD in addition to standardized analgesic protocol

Clinical Study ID

NCT04472416
2020-00091
  • Ages > 18
  • All Genders

Study Summary

We aim to study the use of a virtual reality device (VRD) in addition to our standardized analgesic care protocol for abdominal bedside VAC dressing change and we hypothesize to decrease pain and anxiety and to increase patients' comfort by this intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients requiring a bedside abdominal VAC dressing change
  • Patients above 18 years old
  • Patients able to give informed consent as documented by signature

Exclusion

Exclusion Criteria:

  • Patients under 18 years old
  • Patients with impaired cognitive status
  • Patients with known psychiatric disorders
  • Patients unable to follow the procedures of the study due to language problems
  • Not consent provided
  • Prior inclusion in the same trial (only 1 VAC dressing change per patient can bestudied, the first one)
  • Pregnant patients

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: VRD in addition to standardized analgesic protocol
Phase:
Study Start date:
April 21, 2021
Estimated Completion Date:
September 19, 2023

Study Description

Monocentric non-blinded superiority randomized controlled trial: standardized analgesic protocol + virtual reality device vs. standardized analgesic protocol alone for abdominal VAC dressing change.

The day of the procedure, each patient will receive a standardized local and systemic analgesia 30 minutes before starting the procedure. The referring surgeon will explain at this moment every step of the procedure of bedside abdominal VAC dressing change.

Baseline levels of pain and anxiety will be assessed by use of VAS (0-10) and one additional questionnaire (STAI).

Virtual reality device will be activated 15 minutes before the beginning of the procedure and will remain as long as the procedure is going on and for 15minutes after finishing the wound dressing.

15 minutes after removing the VRD and 30minutes after finishing the wound dressing the STAI questionnaire and VAS for anxiety, pain and satisfaction (0-10) will be completed by the patient.

Connect with a study center

  • Department of Visceral Surgery, University Hospital Center

    Lausanne, 1011
    Switzerland

    Site Not Available

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