Virtual Reality During Intrathecal Pump Refills in Children
VAMPIRE
1 other identifier
interventional
6
1 country
1
Brief Summary
The aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedMarch 18, 2022
March 1, 2022
12 months
January 26, 2021
March 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity
Pain intensity will be assessed with the Wong-Baker FACES scale in children, parents, physician and researcher, to evaluate differences in the 3 conditions (usual refill, refill with VR and refill with distraction).
Through study completion, an average of 6 months.
Secondary Outcomes (5)
Procedural pain
Through study completion, an average of 6 months.
Fear
Through study completion, an average of 6 months.
Anxiety
Through study completion, an average of 6 months.
Statisfaction
Through study completion, an average of 6 months.
Adverse events
Through study completion, an average of 6 months.
Study Arms (3)
Usual care
OTHERPump refill will be performed as usual.
Virtual Reality
OTHERChildren will play a commercially available VR game during pump refill
Distraction
OTHERChildren will watch a commercial 360° music video on YouTube during pump refill
Interventions
Eligibility Criteria
You may qualify if:
- Children with cerebral palsy between 8 and 16 years who have an implanted pump for intrathecal drug delivery
- Child and parents have been informed of the study procedures and have given written informed consent
- Child and parents willing to comply with study protocol
- Child and parents are able to speak Dutch/French (questionnaires)
- Cognitive and language functioning enabling communication between the physician/researcher and the child
You may not qualify if:
- Children with susceptibility to motion sickness or cyber-sickness
- Children with susceptibility to claustrophobia
- History of seizures/epilepsia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
Study Sites (1)
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 26, 2021
First Posted
February 4, 2021
Study Start
February 10, 2021
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
March 18, 2022
Record last verified: 2022-03