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Virtual Reality for pain and fear relief in wound care

Determination of size and characteristics of the target population for the successful application of Virtual Reality during painful (wound) procedures: a prospective non-randomized interventional study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16621834
Enrollment
200
Registered
2021-04-01
Start date
2020-01-06
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns and other traumatic, infectious, or immune-mediated skin and soft tissue lesions Injury, Occupational Diseases, Poisoning Burns and other traumatic, infectious, or immune-mediated skin and soft tissue lesions

Interventions

All participants will receive Virtual Reality (VR) aimed at inducing distraction and/or dissociation and reducing procedural pain and fear. VR-technology will be explained and applied by trained study

Sponsors

Universitair Ziekenhuis Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Mental age =6 years 2. Need for wound care 3. Admitted to E519 (Burn center unit) or ad-hoc patients selected in Pediatric Intensive Care Unit, Outpatient Burn Care, or Emergency Department 4. Able to communicate in Dutch, English, French language

Exclusion criteria

Exclusion criteria: 1. Deaf 2. Blind 3. Schizophrenia, advanced dementia, dissociative disorder, or serious claustrophobia 3. Lesions exclusively in the facial area, precluding VR application during wound care 4. Permanent hypoesthesia in the affected area 5. No informed consent given

Design outcomes

Primary

MeasureTime frame
1. Proportion of patients successfully completing procedures with VR within all patients admitted measured from eCRF records collected at the end of the study 2. Fraction of wound care procedures successfully conducted with VR within all procedures measured from eCRF records collected at the end of the study 3. Predictability of successful VR based on psychological variables and baseline clinical characteristics measured using scored in real time by the study psychologist or study nurse in the eCRF after the procedure

Secondary

MeasureTime frame
1. Extent to which the patient has the experience to be present in “another world” due to diverted attention (potentially related to analgesic and anxiolytic effect) measured using the question "To what extent did you feel you ‘went into” the virtual world?" (not at all/not really/undecided/somewhat/very much) after each procedure 2. Persistence of the analgesic and anxiolytic effect and patient satisfaction in patients undergoing multiple VR sessions measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much), "Have you enjoyed the VR session?" (not at all/not really/undecided/somewhat/very much), "How satisfied were you with the virtual reality system during your dressing change?" (not at all/not really/undecided/somewhat/very much), and "If you would need wound care tomorrow would you like to have VR assistance again?” (yes/no, if no participants will be asked to provide the reason why not) after each procedure; participants will also be asked for their overall satisfaction with the VR equipment (not at all/not really/undecided/somewhat/very much) at the end of the study 3. Healthcare provider satisfaction with VR measured using the following at the end of the study: 3.1. Nurse satisfaction measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much) and "To what extent did you feel the VR equipment interfered with clinical care?" (not at all/not really/undecided/somewhat/very much) 3.2. Physiotherapists’ satisfaction (only for procedures with research physiotherapists available) measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much) and "To what extent did you feel the VR equipment interfered with clinical care?" (not at all/not really/un

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026