Clinical trial NCT05744024: Non-pharmacological Pain Care During Complex Wound Care Procedures
Official title: Non-pharmacological Pain Care Using Virtual Reality Therapy or Music Therapy During Complex Wound Care in Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Wound Surgical
Wounds and Injuries
Virtual Reality
Wound Care
Music Therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
timeFrame: Baseline, during the procedure, immediately after procedure
Secondary outcomes:
measure: Mean VAS change of all wound care procedures included in the study
timeFrame: Baseline, during the procedure, immediately after procedure
measure: Change from baseline in level of anxiety at 10 minutes after procedure
timeFrame: Baseline, 10 minutes after procedure
measure: Patient satisfaction
timeFrame: Through study completion, an average of 1 week
measure: Provider satisfaction
timeFrame: Through study completion, an average of 1 year
measure: Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure
timeFrame: Baseline, 5 minutes after procedure
measure: Change of systolic blood pressure and diastolic blood pressure during procedure
timeFrame: During procedure
measure: Change from baseline blood oxygen level at 5 minutes after procedure
timeFrame: Baseline, 5 minutes after procedure
measure: Change of blood oxygen level during procedure
timeFrame: During procedure
measure: Change from baseline pulse rate at 5 minutes after procedure
timeFrame: Baseline, 5 minutes after procedure
measure: Change of pulse rate during procedure
timeFrame: During procedure
measure: Change from baseline respiratory rate at 5 minutes after procedure
timeFrame: Baseline, 5 minutes after procedure
measure: Change of respiratory rate during procedure
timeFrame: During procedure
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marlies Schijven, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: