Procedural PainNCT03985930
Non-immersive Virtual Reality for Pediatric Pain Management
A study testing Distraction with virtual reality and Treatment as Usual in people with Procedural Pain, run by Claudia Aristizábal at 1 site in Colombia.
Trial summary
This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Distraction with virtual reality and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2020to 1 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.
Who cannot join
- Fever (Axillary temperature greater than 38°C).
- Systemic Inflammatory Response Syndrome or Sepsis.
- Pulmonary disease.
- Neurological deficit of any kind.
- Susspected or confirmed metabolic disease.
- Undernutrition or obesity as defined by deviations from the mean of local values.
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
Read the detailed description
Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.
Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.
Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.
Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.
- Conditions
- Procedural Pain
- Being tested
- Distraction with virtual reality, Treatment as Usual
- Keywords
- Child, Preschool, Virtual Reality, Procedural Pain, Phlebotomy, Vaccination
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction with virtual realityDevice
Distraction content delivered through virtual reality goggles
Treatment as UsualOther
Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| Distraction Group | Experimental | Children between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles. Receives: Device: Distraction with virtual reality |
| Treatment as Usual | Active comparator | Children randomized to this group will receive the usual medical care. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
LLANTO Pain level: LLANTO pain scale
Overall pain assessment using the LLANTO pain scale (Mild: 0-3, Moderate 4-6, Intense 7-10) For more information about LLANTO scale, please visit DOI: 10.1016/j.anpedi.2010.08.005
Measured: Immediately after procedure
Secondary outcomes (6)
LLANTO Crying
Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).
Measured: Immediately after procedure
LLANTO Attitude
Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).
Measured: Immediately after procedure
LLANTO Breathing
Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).
Measured: Immediately after procedure
LLANTO Facial expression
Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).
Measured: Immediately after procedure
LLANTO Postural muscle tone
Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).
Measured: Immediately after procedure
Interrater reliability of the LLANTO scale
Between parents, nurse and physician
Measured: During the statistical analysis stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Nov 2020
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas University
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Jhon H Camacho Cruz, M.D., Principal investigator, Fundación Universitaria Sanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985930
- Sponsor's protocol ID
- VRPedPain
- Status last verified
- Mar 2023
- First submitted
- 11 Jun 2019
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camacho-Cruz J, Palacios-Ariza MA, Orrego-Celestino L, Valbuena-Velandia N, Paez-Castellanos L, Bolanos JM, Pradilla I. Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial. Eur J Pediatr. 2023 Sep;182(9):4103-4112. doi: 10.1007/s00431-023-05070-5. Epub 2023 Jul 5.
PubMed 37407711
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-immersive Virtual Reality for Pediatric Pain Management
- ClinicalTrials.gov ID
- NCT03985930
- Acronym / sponsor ID
- VRPedPain
- Conditions
- Procedural Pain
- Keywords
- Child, Preschool, Virtual Reality, Procedural Pain, Phlebotomy, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Sanitas University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Jun 2019 (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.
This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
Detailed description
Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.
Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.
Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.
Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction Group | Experimental | Device: Distraction with virtual realityChildren between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualChildren randomized to this group will receive the usual medical care. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.
Key exclusion criteria (6 listed)
- Fever (Axillary temperature greater than 38°C).
- Systemic Inflammatory Response Syndrome or Sepsis.
- Pulmonary disease.
- Neurological deficit of any kind.
- Susspected or confirmed metabolic disease.
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 |
|---|---|---|
| Distraction with virtual realityDistraction content delivered through virtual reality goggles | Device | Distraction Group |
| Treatment as UsualTreatment as Usual | Other | Treatment as Usual |
Primary outcome
LLANTO Pain level: LLANTO pain scale
Time frame: Immediately after procedure
Overall pain assessment using the LLANTO pain scale (Mild: 0-3, Moderate 4-6, Intense 7-10) For more information about LLANTO scale, please visit DOI: 10.1016/j.anpedi.2010.08.005
6 secondary outcomes
LLANTO Crying
Time frame: Immediately after procedure
LLANTO Attitude
Time frame: Immediately after procedure
LLANTO Breathing
Time frame: Immediately after procedure
LLANTO Facial expression
Time frame: Immediately after procedure
LLANTO Postural muscle tone
Time frame: Immediately after procedure
Interrater reliability of the LLANTO scale
Time frame: During the statistical analysis stage
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 3 Apr 2023.
- Derived from this study: PubMed 37407711Camacho-Cruz J, Palacios-Ariza MA, Orrego-Celestino L, Valbuena-Velandia N, Paez-Castellanos L, Bolanos JM, Pradilla I. Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial. Eur J Pediatr. 2023 Sep;182(9):4103-4112. doi: 10.1007/s00431-023-05070-5. Epub 2023 Jul 5.
- Individual participant dataSharing planned: No
Related trials for Procedural Pain
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Not yet recruiting
Effects of Family-Proxy-Selected Natural Sound Therapy Versus Standardized Natural Sound and Noise Reduction on Procedural Pain During Endotracheal Suctioning in Non-Communicative Mechanically Ventilated Adults: A Four-Arm Randomized Controlled Trial
Procedural Pain During Endotracheal Suctioning
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
Procedural Pain in Newborns
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.
Jhon H Camacho Cruz, M.D. principal investigator
Fundación Universitaria Sanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction with virtual reality and Treatment as Usual in people with Procedural Pain, run by Claudia Aristizábal at 1 site in Colombia.
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 1 inclusion and 6 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 3 Apr 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 Colombia. 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?
LLANTO Pain level: LLANTO pain scale (time frame: Immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985930, which also lists 1 linked publication.
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 3 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.