Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country32 target enrollmentNovember 7, 2023

ConditionsWound Wound and Injuries Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wound
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment: 32
Locations: 1
Primary Endpoint: The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to evaluate the effect on pain of Virtual Reality Therapy as add-on therapy during wound care procedures in adults.

Detailed Description

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system. Patients are randomly assigned to one of two groups: Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual

Registry

clinicaltrials.gov

Start Date

November 7, 2023

End Date

November 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party

Principal Investigator

Marlies P. Schijven

Professor doctor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

•Individuals aged 18 or older with wounds receiving wound care
•Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
•At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.

Exclusion Criteria

•Individuals not being able to understand Dutch language at primary school level
•Individuals not being able to read or write Dutch
•Individuals diagnosed with dementia and/or cognitive impairment
•Individuals diagnosed with epilepsy
•Individuals diagnosed with migraine
•Individuals with severe dizziness and/or nausea
•Individuals with a known history of claustrophobia
•Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
•Individuals who have no feeling in the wound care area
•Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones

Outcomes

Primary Outcomes

The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).

Time Frame: Baseline, during the procedure, immediately after procedur

The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.

Secondary Outcomes

Mean VAS change of all wound care procedures included in the study(Baseline, during the procedure, immediately after procedure)
Provider satisfaction(Through study completion, an average of 1 year)
Change from baseline pulse rate at 5 minutes after procedure(Baseline, 5 minutes after procedure)
Change from baseline blood oxygen level at 5 minutes after procedure(Baseline, 5 minutes after procedure)
Change of blood oxygen level during procedure(During procedure)
Change from baseline in level of anxiety at 10 minutes after procedure(Baseline, 10 minutes after procedure)
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure(Baseline, 5 minutes after procedure)
Change of systolic blood pressure and diastolic blood pressure during procedure(During procedure)
Change of respiratory rate during procedure(During procedure)
Change of pulse rate during procedure(During procedure)
Patient satisfaction(Through study completion, an average of 1 week)
Change from baseline respiratory rate at 5 minutes after procedure(Baseline, 5 minutes after procedure)