Virtual Pain Care Trial

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Wound, Wound and Injuries, Pain

Intervention / Treatment
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* Device: Virtual Reality ('VRelax' VR system)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18 or older with surgical 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 autism 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 >1 wound requiring wound care 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Therapy (Intervention group 1)<br>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)<br>* 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.<br>|
| No Intervention: Care as usual (control group/group 2)<br>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?
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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 of blood oxygen level during procedure | The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure | During 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Care, Virtual Reality, Pain management