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

November 27, 2023 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Department of Visceral Surgery, University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standardized analgesic protocol alone
Abdominal VAC dressing change using an standardized analgesic protocol alone.
Experimental: VRD + standardized analgesic protocol
Abdominal VAC dressing change using standardized analgesic protocol + virtual reality device
Device: VRD in addition to standardized analgesic protocol
Use of VRD in addition to standardized analgesic protoco for abdominal VAC dressing change

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-procedure) and immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-procedure) and immediately after the procedure
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.
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Martin Hubner, Prof, Lausanne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

September 19, 2023

Study Completion (Actual)

September 19, 2023

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on VRD in addition to standardized analgesic protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe