Virtual Pain Care Trial

N/AEnrolling By InvitationNCT05772468

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)32 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wound Wound and Injuries Pain

Interventions

Virtual Reality ('VRelax' VR system)DEVICE

The intervention group 1 will be wearing the 'VRelax' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, and a headphone. The VRelax Application will be used.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

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).

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

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

Secondary Outcomes

Mean VAS change of all wound care procedures included in the study

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

Time frame: Baseline, during the procedure, immediately after procedure

Change from baseline in level of anxiety at 10 minutes after procedure

Level of anxiety, as measured by a Dutch translated and validated modification of the Spielberger State-Trait Inventory-6 (STAI-6) questionnaire 10 minutes before and 10 minutes after each three wound care moments.

Time frame: Baseline, 10 minutes after procedure

Patient satisfaction

Patient satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.

Time frame: Through study completion, an average of 1 week

Provider satisfaction

Provider satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.