Reducing Pain and Anxiety with Virtual Reality at the Emergency department, in children

Reducing Pain and Anxiety with Virtual Reality at the Emergency department, in children - REPAVE-C

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56622

Enrollment

112

Registered

2024-02-19

Start date

2024-11-08

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

traumatic injury

Interventions

VR versus non-VR group (care as usual)

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Aged 8-18 years Medical treatment required after traumatic injury (e.g. wound closure, closed reduction of a fracture / luxation)

Exclusion criteria

Exclusion criteria: o Contact isolation o Resistance o PSA (Procedural Sedation and Analgesia) with propofol, ketamin and/or midazolam o Language barrier o Intellectual disability o History of epilepsy o Hearing impairment o Visual impairment o High energy injury

Design outcomes

Primary

Measure	Time frame
Anxiety reduction (Δ anxiety = preprocedural STAI-C - postprocedural STAI-C). The anxiety score is measured with STAI-C (State-Trait Anxiety Inventory - Children, abbreviated version). The STAI-C score is measured before and after the procedure. The questionnaire consists of 6 items with 3 options: 1) I feel: very calm, calm or not calm 2) I am: very tense, tense or not tense 3) I am: very confused, confused or not confused 4) I feel: very relaxed, relaxed or not relaxed 5) I feel: very satisfied, satisfied or not satisfied 6) I am: very worried, worried or not worried	—

Measure

Time frame

Anxiety reduction (Δ anxiety = preprocedural STAI-C - postprocedural STAI-C). The anxiety score is measured with STAI-C (State-Trait Anxiety Inventory - Children, abbreviated version). The STAI-C score is measured before and after the procedure. The questionnaire consists of 6 items with 3 options: 1) I feel: very calm, calm or not calm 2) I am: very tense, tense or not tense 3) I am: very confused, confused or not confused 4) I feel: very relaxed, relaxed or not relaxed 5) I feel: very satisfied, satisfied or not satisfied 6) I am: very worried, worried or not worried

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Secondary

Measure	Time frame
- Postprocedural anxiety score (STAI-C) - Painreduction (postprocedural painscore - preprocedural pain score) - Pain score after treatment, using WONG-Baker Faces Scale Indicator for Pain - Procedural distress (distress) and coping of a child periprocedural, measured with the CAMPIS-SF score (Child Adult Medical Procedure Interaction Scale - Short Form). - Coping and distress promoting factors by parents and healthcare provider measured with the CAMPIS-SF - VRMS (virtual reality motion sickness) during the procedure - Treatment satisfaction, both child and parents - VR headset use satisfaction, by child, parents and healthcare provider - Duration of treatment in minutes (start treatment to discharge) - Future perspective of using a VR headset for a medical intervention	—

Measure

Time frame

- Postprocedural anxiety score (STAI-C) - Painreduction (postprocedural painscore - preprocedural pain score) - Pain score after treatment, using WONG-Baker Faces Scale Indicator for Pain - Procedural distress (distress) and coping of a child periprocedural, measured with the CAMPIS-SF score (Child Adult Medical Procedure Interaction Scale - Short Form). - Coping and distress promoting factors by parents and healthcare provider measured with the CAMPIS-SF - VRMS (virtual reality motion sickness) during the procedure - Treatment satisfaction, both child and parents - VR headset use satisfaction, by child, parents and healthcare provider - Duration of treatment in minutes (start treatment to discharge) - Future perspective of using a VR headset for a medical intervention

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)