Music Therapy, Virtual Reality, Wound Care, Wounds and Injuries, Wound Surgical
Conditions
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
Interventions
DEVICEVirtual Reality system
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.
OTHERHeadphones
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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 of pulse rate during procedure | During procedure | The pulse rate every 5 minutes during procedure |
| 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) |
| 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 |
Countries
Netherlands
Outcome results
None listed