An interventional study of Virtual Reality system and Headphones in Wound Surgical, Wounds and Injuries and Virtual Reality, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Enrolling by invitation at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
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
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 72 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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.
Device: Virtual Reality system
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.
Other: Headphones
The care as usual group (control group) will receive the care as usual. This group receives neither VRT nor MT during wound care.
The intervention group 1 will be wearing the 'SyncVR' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, a controller, and a headphone. The SyncVR Relax \& Distract Application (SyncVR R\&D) will be used.
Headphones with audio. The patients will be hearing their preferred audio, chosen by patient to relaxing and to offer distraction, through headphones during wound care.
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 procedure
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''.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline, 5 minutes after procedure
Change of blood oxygen level during procedure
The blood oxygen level every 5 minutes during procedure, measured using a pulse oximetry device
Time frame: 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)
Time frame: Baseline, 5 minutes after procedure
Change of pulse rate during procedure
The pulse rate every 5 minutes during procedure
Time frame: 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)
Time frame: Baseline, 5 minutes after procedure
Change of respiratory rate during procedure
The respiratory rate every 5 minutes during procedure
Time frame: During procedure
Plan to share: No
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)