Cerebral PalsyVAMPIRENCT04737668
Virtual Reality During Intrathecal Pump Refills in Children
A study testing Intrathecal pump refill with Virtual Reality, Intrathecal pump refill with distraction and Intrathecal pump refill in people with Cerebral Palsy, run by Moens Maarten at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intrathecal pump refill with Virtual Reality, Intrathecal pump refill with distraction and Intrathecal pump refill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Feb 2021to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with susceptibility to motion sickness or cyber-sickness
- Children with susceptibility to claustrophobia
- History of seizures/epilepsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Intrathecal pump refill with Virtual Reality, Intrathecal pump refill with distraction, Intrathecal pump refill
- Keywords
- Virtual Reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal pump refill with Virtual RealityOther
VR game
Intrathecal pump refill with distractionOther
Video
Intrathecal pump refillOther
daily routine care for pump refill
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Pump refill will be performed as usual. Receives: Other: Intrathecal pump refill |
| Virtual Reality | Other | Children will play a commercially available VR game during pump refill Receives: Other: Intrathecal pump refill with Virtual Reality |
| Distraction | Other | Children will watch a commercial 360° music video on YouTube during pump refill Receives: Other: Intrathecal pump refill with distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 6 months.
Secondary outcomes (5)
Procedural pain
Procedural pain during refill is assessed with the Face, Legs, Activity, Cry, Consolability scale.
Measured: Through study completion, an average of 6 months.
Fear
The degree of fear will be measured using the Child Fear Scale, based on reporting from the child and parent.
Measured: Through study completion, an average of 6 months.
Anxiety
The Children's Anxiety Meter (CAM) will be used to measure anxiety. This scale will be filled in by children and parents.
Measured: Through study completion, an average of 6 months.
Statisfaction
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.
Measured: Through study completion, an average of 6 months.
Adverse events
The incidence of adverse events (nausea, vomiting, motion sickness, dizziness, seizure) will be evaluated after the refill with VR.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start10 Feb 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737668
- Sponsor's protocol ID
- VAMPIRE
- Acronym
- VAMPIRE
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality During Intrathecal Pump Refills in Children: a Randomised Controlled Trial With Crossover Design
- ClinicalTrials.gov ID
- NCT04737668
- Acronym / sponsor ID
- VAMPIRE / VAMPIRE
- Conditions
- Cerebral Palsy
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Other: Intrathecal pump refillPump refill will be performed as usual. |
| Virtual Reality | Other | Other: Intrathecal pump refill with Virtual RealityChildren will play a commercially available VR game during pump refill |
| Distraction | Other | Other: Intrathecal pump refill with distractionChildren will watch a commercial 360° music video on YouTube during pump refill |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Children with susceptibility to motion sickness or cyber-sickness
- Children with susceptibility to claustrophobia
- History of seizures/epilepsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal pump refill with Virtual RealityVR game | Other | Virtual Reality |
| Intrathecal pump refill with distractionVideo | Other | Distraction |
| Intrathecal pump refilldaily routine care for pump refill | Other | Usual care |
Primary outcome
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).
5 secondary outcomes
Procedural pain
Time frame: Through study completion, an average of 6 months.
Fear
Time frame: Through study completion, an average of 6 months.
Anxiety
Time frame: Through study completion, an average of 6 months.
Statisfaction
Time frame: Through study completion, an average of 6 months.
Adverse events
Time frame: Through study completion, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal pump refill with Virtual Reality, Intrathecal pump refill with distraction and Intrathecal pump refill in people with Cerebral Palsy, run by Moens Maarten at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.