Virtual Reality Distraction Therapy in Paediatrics

NCT06039462 | Completed

• 1 other identifier: PA21/140676
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Child Behavior

Outcome Measures

Primary Outcomes (1)

• Reduction in fear and anxiety associated with treatment.

  Questionnaire (x1) completed at the time of intervention

  24 hours

Study Arms (1)

Children undergoing surgery

OTHER

Behavioral: Application of a virtual reality headset

Interventions

Application of a virtual reality headset BEHAVIORAL

Use of a headset to experience a different reality

Children undergoing surgery

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants will not be recruited if they or their parent/guardian believe the child will not engage or cannot engage with procedural distraction.
• 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.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hopsital NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 15, 2023
• Study Start: September 23, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)