Virtual reality distraction for needle-related pain and distress in children and adolescents with autism spectrum disorder (ASD)
Not Applicable
- Conditions
- Children and adolescents with a diagnosis of Autism Spectrum Disorder (ASD) with or without a co-occurring Intellectual Disability (ID).Mental and Behavioural Disorders
- Registration Number
- ISRCTN14514643
- Lead Sponsor
- Ollscoil na Gaillimhe – University of Galway
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. Children and adolescents with a diagnosis of Autism Spectrum Disorder (ASD) with or without a co-occurring Intellectual Disability (ID), and their parents/legal caregivers
2. Have a venipuncture scheduled or attend the day ward and require a venipuncture.
Exclusion Criteria
1. Children under the age of 5 years and over the age of 18 years
2. Have not been clinically diagnosed as having ASD/ASD-ID
3. Children/adolescents with medical conditions that preclude virtual reality use such as epileptic seizures and vision problems
4. The inability to obtain consent from a parent/legal caregiver, and assent from a child
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. A task analysis of the venipuncture is gathered during the procedure<br>2. Pain is measured using a visual analogue scale (VAS) after the procedure<br>3. Feasibility data related to wearing the VR headset will be gathered after the procedure
- Secondary Outcome Measures
Name Time Method Parent and Nurse/Phlebotomist Measures:<br>1. Behaviour measured by Behaviour Observation Checklist during the venipuncture.<br>2. Pain measured by visual analogue scale (VAS) during the procedure<br>3. Satisfaction with VR and venipuncture measured using Likert rating scales after the procedure