Virtual Pain Care Trial

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Wound; Wound and Injuries
• Intervention / Treatment: Device: Virtual Reality ('VRelax' VR system)

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

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Amsterdam University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Therapy (Intervention group 1); In addition to the standard wound care procedure, the Virtual Reality Therapy group (intervention group 1) will receive the VR system during the wound care. The VR system consists of Virtual Reality glasses, and a headphone. The application VRelax will be used, which will contain various videos for the patient those from to relax and be distracted. This group wears the VR system 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.	Device: Virtual Reality ('VRelax' VR system); 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.
No Intervention: Care as usual (control group/group 2); The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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''.	Baseline, during the procedure, immediately after procedur

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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''.	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.	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''.	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''.	Through study completion, an average of 1 year
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure	The systolic blood pressure and diastolic blood pressure 5 minutes before the intervention (intervention group)/wound care (control group) and 5 minutes after the intervention (intervention group)/wound care (control group)	Baseline, 5 minutes after procedure
Change of systolic blood pressure and diastolic blood pressure during procedure	The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure	During procedure
Change from baseline blood oxygen level at 5 minutes after procedure	The blood oxygen level, measured using a pulse oximetry device, 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)	Baseline, 5 minutes after procedure
Change from baseline pulse rate at 5 minutes after procedure	The pulse rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)	Baseline, 5 minutes after procedure
Change of pulse rate during procedure	The pulse rate every 5 minutes during procedure	During procedure
Change from baseline respiratory rate at 5 minutes after procedure	The respiratory rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)	Baseline, 5 minutes after procedure
Change of respiratory rate during procedure	The respiratory rate every 5 minutes during procedure	During procedure
Change of blood oxygen level during procedure	The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure	During procedure

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Marlies Schijven, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; Virtual Reality; Wound Care
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NL82360.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No