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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05744024
Other study ID # NL82062.018.22
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 17, 2022
Est. completion date November 17, 2024

Study information

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

Clinical Trial 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 care at the surgical wards in adults.


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


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Virtual 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.
Other:
Headphones
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.

Locations

Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

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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