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

• ClinicalTrials.gov Identifier: NCT04472416
• Recruitment Status: Recruiting
• First Posted: July 15, 2020
• Last Update Posted: March 7, 2022
• Sponsor: University of Lausanne Hospitals
• Information provided by (Responsible Party): Nicolas DEMARTINES, University of Lausanne Hospitals

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain; Anxiety; Satisfaction, Patient	Device: VRD in addition to standardized analgesic protocol	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Monocentric non-blinded superiority randomized controlled trial: standardized analgesic protocol + virtual reality device vs. standardized analgesic protocol alone for abdominal VAC dressing change.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change - A Randomized Controlled Clinical Trial (VIRPA)
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Martin Hubner, Prof; 00410795561506; Martin.Hubner@chuv.ch

Contact: Beatriz Barbera Carbonell, MD; 00410795568493; Beatriz.Barbera-Carbonell@chuv.ch

Locations

Switzerland

Department of Visceral Surgery, University Hospital Center; Recruiting

Lausanne, Switzerland, 1011

Contact: Martin Hubner, MD +41 21 314 2418 martin.hubner@chuv.ch

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

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

More Information

Publications:

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• Responsible Party: Nicolas DEMARTINES, Prof., University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT04472416
• Other Study ID Numbers: 2020-00091
• First Posted: July 15, 2020
• Last Update Posted: March 7, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:

Virtual reality; Pain; Anxiety; Satisfaction; VAC dressing change

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs