Smartphone virtual reality exposure before MRI: effects on pre- and periprocedural anxiety. A multicenter RCT

• Conditions: thorax; MRI for head; angstbeleving bij diagnostisch onderzoek; and abdomen

• Registration Number: NL-OMON52443
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

Consecutive pediatric patients (aged 6-14 years), undergoing MRI at the Sophia
Children*s Hospital and the Amsterdam UMC-Emma Children's Hospital between
April 2020 and December 2022.

Exclusion Criteria

Mental retardation (due to a specified syndrome), inability of parents to read
or write Dutch, epilepsy, or visual impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is anxiety immediately prior to MRI (T2). This is<br /><br>measured with a VAS scale assessed by children, the researcher observes child<br /><br>anxiety by means of a VAS and a short questionnaire for children aged 8 years<br /><br>and older wil be filled out by children about their anxiety level (State trait<br /><br>anxiety inventory-children).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br><br /><br>- Anxietyof the child and parents at home (T1) and after the MRI (T2)<br /><br>- Use of sedation and anesthesia<br /><br>- Quality of the MRI images<br /><br>- Duration of the MRI </p><br>