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

NCT04472416 | Completed DMC

• 1 other identifier: 2020-00091
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Satisfaction, Patient

Keywords

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

Outcome Measures

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.

  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 Outcomes (2)

• 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.

  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.

  Immediately after the procedure

Study Arms (2)

Standardized analgesic protocol alone

NO INTERVENTION

Abdominal VAC dressing change using an standardized analgesic protocol alone.

VRD + standardized analgesic protocol

EXPERIMENTAL

Abdominal VAC dressing change using standardized analgesic protocol + virtual reality device

Device: VRD in addition to standardized analgesic protocol

Interventions

VRD in addition to standardized analgesic protocol DEVICE

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

VRD + standardized analgesic protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Pregnant patients

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

Location

Related Publications (17)

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MeSH Terms

Conditions

Pain; Anxiety Disorders; Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Martin Hubner, Prof

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

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

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 15, 2020
• Study Start: April 21, 2021
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)