Status:
COMPLETED
Virtual Reality Distraction Therapy in Paediatrics
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Child Behavior
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
For many children in hospital, having blood tests or cannulation is a significantly distressing event physically, psychologically and emotionally. Use of distraction during invasive procedures is alre...
Detailed Description
Not all studies raise significant issues. Some studies may have straightforward ethical or other issues that can be identified and managed routinely. Others may present significant issues requiring fu...
Eligibility Criteria
Inclusion
- Paediatric patient, aged 8-12 years or 13-18 years.
- Under care of paediatric department - as inpatient
- Requiring invasive procedure - including (but not limited to) blood sampling (venepuncture), siting intravenous access (cannulation, long line, Port-a-cath access), lumbar puncture, other device insertion or removal (e.g. catheter, drain, cardiac pacing wires, intra-thecal baclofen pump refills), minor surgical bedside procedures.
- Consents to study - either child with mental capacity, or parent/legal guardian on behalf of their child.
Exclusion
- Participants will not be recruited if they or their parent/guardian believe the child will not engage or cannot engage with procedural distraction.
- Participants will not be recruited to the VR group if he/she meets any of the following exclusion criteria:
- Patients not under care of paediatrics (over 18 years of age)
- If the child has previously been recruited to the study - each child may only be in the study once
- Contraindications to use of VR or the VR headset
- Inability to wear headset - facial or skull injury/fracture
- Marked reduced visual acuity or blindness
- Interference with care - e.g. requirement of other medical equipment that cannot be worn/administered simultaneously with VR e.g. non-invasive ventilation.
- Pre-procedure dizziness, nausea, vertigo
- History of photosensitive epilepsy
- Potential for poor cooperation with procedure (hence risk of moving) - this is more likely in the age range 8-12 years old. Prior discussion to be held with parents through PIL and consent form to judge if the child is likely to be cooperative.
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06039462
Start Date
September 23 2021
End Date
December 13 2021
Last Update
September 15 2023
Active Locations (1)
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1
Leeds Teaching Hopsital NHS Trust
Leeds, United Kingdom, LS9 7TF