Child BehaviorNCT06039462
Virtual Reality Distraction Therapy in Paediatrics
A study testing Application of a virtual reality headset in people with Child Behavior, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Child Behavior
- What is being tested?
- Application of a virtual reality headset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2021to 13 Dec 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Not all studies raise significant issues. Some studies may have straightforward ethical or other issues that can be identified and managed routinely. Others may present significant issues requiring further consideration by a REC, HRA, or other review body (as appropriate to the issue). Studies that present a minimal risk to participants may raise complex organisational or legal issues. You should try to consider all the types of issues that the different reviewers may need to consider.
VR companies do not recommend use of their headsets in children under 13 years of age. I do not anticipate including 8-12 year olds in the study causing any issues based on experience and advice from relevant experts (see below). In summary, the age cut off is borne of lack of evidence for long-term effects of VR on visual or brain development, rather than specific concerns or evidence existing to inform the age cut off.
Children's Hospital Colorado (US) use VR in children of 6 years and above. Speaking with their Associate Professor of Paediatrics, the age limitation is not derived from medical standards or concerns. They discussed with their Neurology department who agreed there is no age-specific concern that warrants the 12 year cut-off, and they also rely upon the professional expertise of Child Life Specialists who routinely screen toys and devices for age-appropriate application. They have used VR in healthcare for children several hundred times and have no concerns about the age cut off the VR companies suggest.
Stanford University School of Medicine (US) run the highest volume clinical VR therapy program in the US, with thousands of children each year receiving VR. Their department similarly does not exclude under 13 year olds from their program.
Clinicians experienced with VR in the UK have spoken to VR companies involved in their studies, and the information gives was that there no long-term data on VR and its effects on brain and visual development. These clinicians also use VR on children aged 5-6 years and above.
I have met with the VR company Dubit Limited, which shows in its global trends data that children much younger than 13 are already using VR. The publication "Children and Virtual Reality: Emerging Possibilities and Challenges" contains data from studies looking at the 8-12 year old age group; there is not any current evidence of adverse events in this age group, though transient change to visual function has been seen only in a minority of VR users in this age group.
- Conditions
- Child Behavior
- Being tested
- Application of a virtual reality headset
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a virtual reality headsetBehavioural
Use of a headset to experience a different reality
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing surgery | Other | Not described Receives: Behavioral: Application of a virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in fear and anxiety associated with treatment.
Questionnaire (x1) completed at the time of intervention
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start23 Sep 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039462
- Sponsor's protocol ID
- PA21/140676
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06039462
- Acronym / sponsor ID
- PA21/140676
- Conditions
- Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 15 Sep 2023 (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.
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.
Detailed description
Not all studies raise significant issues. Some studies may have straightforward ethical or other issues that can be identified and managed routinely. Others may present significant issues requiring further consideration by a REC, HRA, or other review body (as appropriate to the issue). Studies that present a minimal risk to participants may raise complex organisational or legal issues. You should try to consider all the types of issues that the different reviewers may need to consider.
VR companies do not recommend use of their headsets in children under 13 years of age. I do not anticipate including 8-12 year olds in the study causing any issues based on experience and advice from relevant experts (see below). In summary, the age cut off is borne of lack of evidence for long-term effects of VR on visual or brain development, rather than specific concerns or evidence existing to inform the age cut off.
Children's Hospital Colorado (US) use VR in children of 6 years and above. Speaking with their Associate Professor of Paediatrics, the age limitation is not derived from medical standards or concerns. They discussed with their Neurology department who agreed there is no age-specific concern that warrants the 12 year cut-off, and they also rely upon the professional expertise of Child Life Specialists who routinely screen toys and devices for age-appropriate application. They have used VR in healthcare for children several hundred times and have no concerns about the age cut off the VR companies suggest.
Stanford University School of Medicine (US) run the highest volume clinical VR therapy program in the US, with thousands of children each year receiving VR. Their department similarly does not exclude under 13 year olds from their program.
Clinicians experienced with VR in the UK have spoken to VR companies involved in their studies, and the information gives was that there no long-term data on VR and its effects on brain and visual development. These clinicians also use VR on children aged 5-6 years and above.
I have met with the VR company Dubit Limited, which shows in its global trends data that children much younger than 13 are already using VR. The publication "Children and Virtual Reality: Emerging Possibilities and Challenges" contains data from studies looking at the 8-12 year old age group; there is not any current evidence of adverse events in this age group, though transient change to visual function has been seen only in a minority of VR users in this age group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing surgery | Other | Behavioral: Application of a virtual reality headset |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Application of a virtual reality headsetUse of a headset to experience a different reality | Behavioural | Children undergoing surgery |
Primary outcome
Reduction in fear and anxiety associated with treatment.
Time frame: 24 hours
Questionnaire (x1) completed at the time of intervention
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 15 Sep 2023.
- Individual participant dataSharing planned: No
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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 Application of a virtual reality headset in people with Child Behavior, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 11 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 15 Sep 2023. 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 United Kingdom. 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?
Reduction in fear and anxiety associated with treatment. (time frame: 24 hours). 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 15 Sep 2023.