Virtual RealityRealPEDNCT05902585
Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)
A study testing Virtual reality in people with Virtual Reality and Pediatric ALL, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 6 sites in Spain.
Trial summary
The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test. Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Pediatric ALL, Pain, Procedural
- What is being tested?
- Virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 6 sitesSpain
- Study dates
- 26 Feb 2022to 2 Nov 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
- Consent to participate by signing the informed consent.
Who cannot join
- Children younger than 7 years old.
- Children older than 12 years old.
- Children that don't sign the informed consent.
- Children with psychomotor and neurocognitive delay.
- Children with visual or hearing impairment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Centre de Salut de Carcer
Càrcer, Valencia, 46294
Centre de Salut de Castelló
Castellon, Valencia, 46270
Centre de Salut de Pobla Llarga
La Pobla Llarga, Valencia, 46670
Hospital General de Onteniente
Ontinyent, Valencia, 46870
Centre de Salut de Xàtiva
Xàtiva, Valencia, 46800
Hospital Lluís Alcanyís
Xàtiva, Valencia, 46800
About this study
Official title: Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.
Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.
The satisfaction of parents and nursing will also be analyzed.
- Conditions
- Virtual Reality, Pediatric ALL, Pain, Procedural
- Being tested
- Virtual reality
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | In this arm, the analysis will be done in the usual way (for example, distracting with questions). |
| Virtual reality | Active comparator | In this arm, the analysis will be done while the children use virtual reality. Receives: Behavioral: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain associated with venipuncture
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
Measured: 1 day: The day of the venipuncture
Anxiety
Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.
Measured: 1 day: The day of the venipuncture
Secondary outcomes (5)
Number of attempts for analytics
1, 2, 3, 4, or 5
Measured: 1 day: The day of the venipuncture
Time required for analysis
Minutes
Measured: 1 day: The day of the venipuncture
Difficulty level of the technique
Easy, normal or difficult
Measured: 1 day: The day of the venipuncture
Parents satisfaction
1 = unsatisfied 10 = very satisfied
Measured: 1 day: The day of the venipuncture
Nurse anxiety
1 = totally calm 10 = very anxious
Measured: 1 day: The day of the venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start26 Feb 2022
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Gil Piquer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Raquel Gil Piquer, Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902585
- Sponsor's protocol ID
- 37/2021
- Acronym
- RealPED
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05902585
- Acronym / sponsor ID
- RealPED / 37/2021
- Conditions
- Virtual Reality, Pediatric ALL, Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 15 Jun 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.
The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.
Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.
The satisfaction of parents and nursing will also be analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –In this arm, the analysis will be done in the usual way (for example, distracting with questions). |
| Virtual reality | Active comparator | Behavioral: Virtual realityIn this arm, the analysis will be done while the children use virtual reality. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
- Consent to participate by signing the informed consent.
Key exclusion criteria (5 listed)
- Children younger than 7 years old.
- Children older than 12 years old.
- Children that don't sign the informed consent.
- Children with psychomotor and neurocognitive delay.
- Children with visual or hearing impairment.
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 |
|---|---|---|
| Virtual realityIn the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture. | Behavioural | Virtual reality |
Primary outcome
Pain associated with venipuncture
Time frame: 1 day: The day of the venipuncture
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
Anxiety
Time frame: 1 day: The day of the venipuncture
Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.
5 secondary outcomes
Number of attempts for analytics
Time frame: 1 day: The day of the venipuncture
Time required for analysis
Time frame: 1 day: The day of the venipuncture
Difficulty level of the technique
Time frame: 1 day: The day of the venipuncture
Parents satisfaction
Time frame: 1 day: The day of the venipuncture
Nurse anxiety
Time frame: 1 day: The day of the venipuncture
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 Jun 2023.
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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.
Raquel Gil Piquer principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Virtual Reality and Pediatric ALL, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 6 sites in Spain.
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 2 inclusion and 5 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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 associated with venipuncture (time frame: 1 day: The day of the venipuncture). The study lists 2 primary outcomes in all. 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 Jun 2023.