Virtual Reality Clinical Trial
Official title:
Non-pharmacological Pain Care Using Virtual Reality Therapy or Music Therapy During Complex Wound Care in Adults at Surgical Nursing Wards
Verified date | February 2023 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 care at the surgical wards in adults.
Status | Enrolling by invitation |
Enrollment | 180 |
Est. completion date | November 17, 2024 |
Est. primary completion date | November 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals aged 18 or older who are admitted to the surgical nursing wards having 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 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Center | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 procedure | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change of blood oxygen level during procedure | The blood oxygen level every 5 minutes during procedure, measured using a pulse oximetry device | During procedure | |
Secondary | 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 | |
Secondary | Change of pulse rate during procedure | The pulse rate every 5 minutes during procedure | During procedure | |
Secondary | 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 | |
Secondary | Change of respiratory rate during procedure | The respiratory rate every 5 minutes during procedure | During procedure |
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