Non-pharmacological Pain Care During Complex Wound Care Procedures

Not Applicable

• Conditions: Virtual Reality; Wound Care; Music Therapy; Wounds and Injuries; Wound Surgical
• Interventions: Device: Virtual Reality system; Other: Headphones

• Registration Number: NCT05744024
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car 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 1:1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system or headphone with audio during wound care or not wearing the VR system or headphone with audio.

Patients are randomly assigned to one of three groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Intervention group 2, Music Therapy Group 3 - Control group, care as usual

Study Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-11-17
• Study Completion: 2025-11-17

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Individuals aged 18 or older who have wounds receiving wound care
• Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures before discharge
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Therapy (Intervention group 1)	Virtual Reality system	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, a controller and a headphone. The application SyncVR Relax \& Distract 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.
Music Therapy (Intervention group 2)	Headphones	In addition to the standard wound care procedure, the Music Therapy group (intervention group 2) will be hearing their preferred audio, chosen by patient to be relaxing and to offer distraction, through headphones during wound care. This group wears the headphone with music 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).	Baseline, during the procedure, immediately after procedure	The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.

Secondary Outcome Measures

Name	Time	Method
Mean VAS change of all wound care procedures included in the study	Baseline, during the procedure, immediately after procedure	The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Change from baseline in level of anxiety at 10 minutes after procedure	Baseline, 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.
Patient satisfaction	Through study completion, an average of 1 week	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''.
Provider satisfaction	Through study completion, an average of 1 year	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''.
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure	Baseline, 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)
Change from baseline blood oxygen level at 5 minutes after procedure	Baseline, 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)
Change of pulse rate during procedure	During procedure	The pulse rate every 5 minutes during procedure
Change of respiratory rate during procedure	During procedure	The respiratory rate every 5 minutes during procedure
Change of systolic blood pressure and diastolic blood pressure during procedure	During procedure	The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure
Change of blood oxygen level during procedure	During procedure	The blood oxygen level every 5 minutes during procedure, measured using a pulse oximetry device
Change from baseline pulse rate at 5 minutes after procedure	Baseline, 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)
Change from baseline respiratory rate at 5 minutes after procedure	Baseline, 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)

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands