Child Behavior Clinical Trial
Official title:
Improve Patient Safety and Wellbeing in Leeds Children Hospital for Patients Undergoing Procedures Through Use of Virtual Reality Distraction Therapy (VRDT), and Improve Their Overall Experience.
Verified date | September 2023 |
Source | The Leeds Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 already common practice in paediatrics to improve the experience both for the child and parents. Use of Virtual Reality (VR) and VR Distraction Therapy (VRDT) is a relatively new concept, but has already shown promising results in studies. "VR offers an interactive distraction technique, a contrast to the passive distraction of reading a book or playing games on a tablet … and [VR] is thought to alter pain perception and the child's interpretation of pain signals." (Cochrane Library - Virtual reality simulation for reducing pain in children). The project aims to collect data about venepuncture, cannulation, long lines - qualitative and quantitative data - from children and parents. This studyl compares current standard practice with VR distraction therapy.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 13, 2021 |
Est. primary completion date | December 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Paediatric patient, aged 8-12 years or 13-18 years. 2. Under care of paediatric department - as inpatient 3. 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. 4. Consents to study - either child with mental capacity, or parent/legal guardian on behalf of their child. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hopsital NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in fear and anxiety associated with treatment. | Questionnaire (x1) completed at the time of intervention | 24 hours |
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