Skip to main content
OpenTrials
Completed

NCT Number: NCT04472416

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Personal Satisfaction Satisfaction, Patient Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 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 be studied, the first one)
  • Pregnant patients

Treatment and study plan

VRD in addition to standardized analgesic protocol

Device

Use of VRD in addition to standardized analgesic protoco for abdominal VAC dressing change

Primary outcomes

  1. Change of pain using a virtual reality device in addition to a standardized analgesic protocol for bedside abdominal VAC dressing change. Pain will be measured by using a visual analogue scale (VAS) for pain (0-10) in the two groups.

    Time frame: Baseline (pre-procedure) and immediately after the procedure

    Measurement of pain using a visual analogue scale (VAS) for pain with scores range from 0 (no pain) and 10 (worst possible pain), before (baseline: pre-procedure) and immediately after bedside abdominal vacuum assisted closure (VAC) dressing change in the two groups (virtual reality device + standardized analgesic protocol and standardized analgesic protocol alone) in order to demonstrate if a virtual reality device can reduce pain when used in addition to standard care.

Secondary outcomes

  1. Change of anxiety using a virtual reality device along with a standardized analgesic protocol for bedside abdominal VAC dressing change. Anxiety will be measured by using, in the 2 groups, a VAS scale for anxiety along with a STAI questionnaire.

    Time frame: Baseline (pre-procedure) and immediately after the procedure

    Measurement of anxiety using the validated questionnaire State Trait Anxiety Inventory (STAI) and a visual analogue scale (VAS) for anxiety from 0 (no anxiety) and 10 (worst possible anxiety), before (baseline: pre-procedure) and immediately after bedside abdominal vacuum assisted closure (VAC) in dressing change in the two groups (virtual reality device + standardized analgesic protocol and standardized analgesic protocol alone) in order to demonstrate if a virtual reality device can reduce anxiety used in addition to standard care.

  2. Assessment of patients satisfaction using a virtual reality device in addition to a standardized analgesic protocol for bedside abdominal VAC dressing change. Satisfaction will be measured by using a visual analogue scale (VAS) for satisfaction.

    Time frame: Immediately after the procedure

    Satisfaction assessment using a visual analogue scale (VAS) from 1 (not satisfied at all) to 10 (very satisfied) in the two groups (virtual reality device + standardized analgesic protocol and standardized analgesic protocol alone) in order to demonstrate if a virtual reality device can increase patients satisfaction when used in addition to standard care. The assessment will be performed immediately after the procedure.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change - A Randomized Controlled Clinical Trial (VIRPA)

Acronym: VIRPA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2020
Registry last updated
Nov 29, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.