on-pharmacological Pain Care using Virtual Reality Therapy or Music Therapy during complex wound care in adults

Recruiting

Conditions: Pain and Anxiety
10040795

Registration Number: NL-OMON53602

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

- Individuals aged 18 or older having wounds receiving wound care
- Individuals who will undergo minimum of 1 to a maximum of 3 sequential
complex wound care* procedures
- 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.
*Complex wound care: Wound care deemed fit for conservative wound care (based
on wound properties, such as: cause, location, size, the necessary
intervention), including necrosectomy at the hospital ward as per regular wound
care protocol

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain score measured with the VAS-score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Level of anxiety, measured with the STAI-6 questionnaire<br /><br>- Length of hospital stay<br /><br>- Patient and provider satisfaction, measured with questionnaires<br /><br>- Blood pressure<br /><br>- Heart rate<br /><br>- Saturation<br /><br>- Respiratory rate </p><br>