Virtual Reality During Intrathecal Pump Refills in Children (VAMPIRE)

March 17, 2022 updated by: Moens Maarten

Virtual Reality During Intrathecal Pump Refills in Children: a Randomised Controlled Trial With Crossover Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Virtual reality (VR) is a technological rehabilitation tool that allows the user to experience the interaction with a computer-generated environment. It may provide some advantages over conventional care: it allows the simulation of realistic environments and patients feel more motivated by this kind of virtual environment. VR constitutes an enriched environment with augmented multiple sensory feedbacks (auditory, visual, tactile VR enriched environment) that has already shown some efficiency in reducing chronic pain. There is mounting evidence from acute pain conditions, such as wound care, that VR could play a role as an additional treatment method to relieve pain A possible explanation for its mechanism of action is provided by "the gate-theory of attention". VR reduces the perception of pain by diverting attention away from the pain. Most children experience pain and fear when receiving a medical treatment; two feelings which are closely related and affecting one another. Moreover, children often describe procedures involving needles as the most stressful portion of the hospital experience. Children who have been implanted with an intrathecal baclofen (ITB) pump, need to come to the hospital for a refill approximately every 3 months, depending on the exact dose. During the refill, the physician places a needle directly into the reservoir to refill the pump. To alleviate the pain and fear with these refill procedures, it is hypothesized that VR could alleviate pain and make these refills more feasible. Therefore, the aim of this study is to evaluate whether VR is reducing pain during a refill procedure, in children receiving intrathecal drug delivery compared to usual care.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Jette, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Children with susceptibility to motion sickness or cyber-sickness
  • Children with susceptibility to claustrophobia
  • History of seizures/epilepsia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual care
Pump refill will be performed as usual.
Other: Intrathecal pump refill
daily routine care for pump refill
Other: Virtual Reality
Children will play a commercially available VR game during pump refill
Other: Intrathecal pump refill with Virtual Reality
VR game
Other: Distraction
Children will watch a commercial 360° music video on YouTube during pump refill
Other: Intrathecal pump refill with distraction
Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Through study completion, an average of 6 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural pain
Time Frame: Through study completion, an average of 6 months.
Procedural pain during refill is assessed with the Face, Legs, Activity, Cry, Consolability scale.
Through study completion, an average of 6 months.
Fear
Time Frame: Through study completion, an average of 6 months.
The degree of fear will be measured using the Child Fear Scale, based on reporting from the child and parent.
Through study completion, an average of 6 months.
Anxiety
Time Frame: Through study completion, an average of 6 months.
The Children's Anxiety Meter (CAM) will be used to measure anxiety. This scale will be filled in by children and parents.
Through study completion, an average of 6 months.
Statisfaction
Time Frame: Through study completion, an average of 6 months.
The statisfaction will be evaluated by two questions, scoring on a 5-point Likert agreement scale, by the children, parents and physician after the refill with VR and after the refill with distraction.
Through study completion, an average of 6 months.
Adverse events
Time Frame: Through study completion, an average of 6 months.
The incidence of adverse events (nausea, vomiting, motion sickness, dizziness, seizure) will be evaluated after the refill with VR.
Through study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moens Maarten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

January 26, 2022

Study Completion (Actual)

January 26, 2022

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAMPIRE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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