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

Conditions: traumatic injury
10017322
10040795

Registration Number: NL-OMON56622

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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