Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT05772468
Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 18 or older with 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.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05772468
Study Brief:
Protocol Section:
NCT05772468