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

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Anxiety
Pain
Satisfaction, Patient

Treatments

Device: VRD in addition to standardized analgesic protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04472416
2020-00091

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Standardized analgesic protocol alone
No Intervention group
Description:
Abdominal VAC dressing change using an standardized analgesic protocol alone.
VRD + standardized analgesic protocol
Experimental group
Description:
Abdominal VAC dressing change using standardized analgesic protocol + virtual reality device
Treatment:
Device: VRD in addition to standardized analgesic protocol

Trial contacts and locations

1

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Central trial contact

Martin Hubner, Prof; Beatriz Barbera Carbonell, MD

Data sourced from clinicaltrials.gov

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