Clinical trial NCT04472416: Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change
Official title: Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change - A Randomized Controlled Clinical Trial (VIRPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Satisfaction, Patient
Keywords: Virtual reality
Pain
Anxiety
Satisfaction
VAC dressing change
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Baseline (pre-procedure) and immediately after the procedure
Secondary outcomes:
measure: 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.
timeFrame: Baseline (pre-procedure) and immediately after the procedure
measure: 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.
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
Study officials:
affiliation: University of Lausanne Hospitals
name: Martin Hubner, Prof
role: PRINCIPAL_INVESTIGATOR
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