Virtual RealityNCT04096833
Virtual Reality for the Treatment of Pain in Pediatric Vaccination
A study testing Virtual Reality Group in people with Virtual Reality and Vaccination, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Objective: to estimate the effect of virtual reality as a distracting technique against traditional distracting techniques in the vaccination procedure in the pediatric population. Design: randomized clinical trial. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Vaccination, Pain
- What is being tested?
- Virtual Reality Group
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Jun 2023
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3 and 14 years old, who attend a pediatric nursing office of the Fuensanta Health Center (Valencia) for immunization by vaccine.
- Children who are accompanied by a caregiver (father, mother, legal guardian) during the procedure.
- That both the child and the caregiver understand and speak Spanish.
- That they have consented to participate in the study: in children by verbal consent and in their father, mother, legal guardian, by signing the informed consent document.
Who cannot join
- Children with sensory problems that prevent the use of RV.
- Children with sensory impairment of pain perception (for example, spina bifida).
- Children who have taken analgesic medication on the day of the puncture, either orally or topically in the puncture area.
- Children with a history of seizures or dizziness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Versus Standard-of-care Treatment on Pain Perception During Paediatric Vaccination: Study Protocol for a Randomised Controlled Trial.
Objective: to estimate the effect of virtual reality as a distracting technique against traditional distracting techniques in the vaccination procedure in the pediatric population.
Design: randomized clinical trial. Field of study: the study will be carried out in the field of pediatric primary care nursing consultation, where the pediatric systematic vaccination is performed.
Read more
Subjects to study: the sample will be made up of children from 3 to 14 years old who are punctured for immunization in the Fuensanta Health Center that belongs to the Department of Health Valencia-General Hospital.
Variables: age, sex, family country of origin, years living in Spain, number of children of the nuclear family, order in the number of siblings, socioeconomic level, age of the caregiver that accompanies the child, affiliation / bond with the child . Group to which the subject belongs (intervention group vs. control group). Number of punctures received in the last year. Heart rate pre and post vaccination. Type of vaccine. Combination of several punctures in the query. Previous use of virtual reality. Level of pain and fear after puncture. Parent or legal guardian satisfaction.
Data collection: it will be held at the Health Center on the same day as the vaccination prodecure. On the part of the nurse (heart rate, type of vaccine, combination of several punctures), the child (pain, fear) and the parents / legal guardian (satisfaction, sociodemographic).
Data analysis: The descriptive analysis of the quantitative variables will be carried out through the calculation of means, typical deviations, medians, ranges, minimum and maximum values. Qualitative variables will be analyzed in absolute and relative frequencies. For the statistical inference analysis, the T-test analysis of mean difference or U-Mann Whitney (according to normal compliance) will be used. All analyzes will be performed with a 95% confidence interval.
Read the detailed description
Process:
The health professional responsible for carrying out the intervention will be the nurse of the pediatric consultation of the Health Center where the study will be carried out. She is the only nurse in this center, so she will be the only professional to perform the procedure on all subjects participating in the study; in this way the variability in the puncture technique is avoided.
The nurse will recruit potential participants who meet inclusion criteria, informing about the research and answering their possible questions. Once participants wishing to be part of the study have signed the informed consent, they will be coded by numbers. These numerical codes will be linked chronologically to the random sequence previously generated by the sealedenvelopeTM software. Once the nurse knows the group to which the participant belongs, she will perform the corresponding intervention.
The evaluation after the completion of the vaccination procedure will be carried out through self-administered scales (by the child for pain and fear variables, and by the caregiver for sociodemographic and satisfaction variables). In addition, the nurse will record data regarding vaccinations.
The data collection time is estimated at 1 year and a half or until the sample size is reached.
Intervention:
The study groups will be determined by the randomization of the sample into two groups: GI and GC. The GI will use as a distracting measure the viewing of VR experiences adapted to their age with the Oculus Go VR glasses during the puncture. The GC will use habitual non-virtual distracting measures: being in the arms of the main caregiver or maintaining physical contact with him (for example, shaking hands) and / or playing or watching videos with the mobile phone of the parents or legal guardian.
- Conditions
- Virtual Reality, Vaccination, Pain, Nursing
- Being tested
- Virtual Reality Group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Participants are from 3 to 14 years old who attend a pediatric primarey health care of the Fuensanta Health Center (Valencia) for immunization by vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants use as a distracting measure Virtual Reality glasses during the vaccination. Receives: Other: Virtual Reality Group |
| Control Group | No intervention | Participants use usual non-virtual distracting measures during the vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the perception of pain in children during the vaccination between participants to recive virtual reality and to recive usual distraction mesures: Wong-Baker FACES scale
El dolor es una experiencia emocional y sensorial desagradable, que puede deberse a un procedimiento terapéutico como la vacunación. Para medir el nivel de dolor del niño después de la vacunación, se utilizará la Escala de calificación del dolor: escala FACES de Wong-Baker. Es un cuestionario validado desarrollado por Bieri en 1990. Está indicado para niños entre 3 y 18 años. La escala va de 0 a 10 y tiene 6 caras. A cada cara se le asigna un puntaje. El primero, con un valor de 0, equivale a "no hurt"; la segunda, con un valor de 2 , equivale a "hurts little bit", el tercero, con un valor de 4 es igual a "hurts little more", el cuarto, con un valor de 6, significa "hurts even more", el quinto, con un valor de 8, es igual a "hurts whole lot" y el último, con un valor de 10 es igual a "hurts worse". Se le pide al paciente que seleccione la cara que mejor describa cómo se siente. En el nivel psicométrico, esta escala se valida r = .90, alfa de Cronbach = .93 (Keck, 1996).
Measured: It is immediately after vaccination.
Secondary outcomes (1)
Compare the perception of fear in children during the vaccination between participants to recive virtual reality and usual distraction mesures.
Vaccination causes fear in children. To assess the fear perceived by the child, the Child Fear Scale (CFS) will be used (McMurtry, Noel, Chambers, McGrath, 2011). CFS consists of five faces that show different levels of fear: the first face, no. 0, the second, no. 1, the third, no. 2, the fourth, no. 3, and the last, no. 4. The first face equals "no fear" and the last "maximum fear possible". The CFS is an effective instrument for measuring fear related to pain during vaccination of children. This tool is validated (Interrater Time 1 reliability: rs = .51, p <.001 and test-retest reliability rs = .76, p <.001).
Measured: It is immediately after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Mar 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura García Garcés, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096833
- Sponsor's protocol ID
- CardenalHU_Nursing
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Keck JF, Gerkensmeyer JE, Joyce BA, Schade JG. Reliability and validity of the Faces and Word Descriptor Scales to measure procedural pain. J Pediatr Nurs. 1996 Dec;11(6):368-74. doi: 10.1016/S0882-5963(96)80081-9.
PubMed 8991337Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
PubMed 29053848
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Versus Standard-of-care Treatment on Pain Perception During Paediatric Vaccination: Study Protocol for a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04096833
- Acronym / sponsor ID
- CardenalHU_Nursing
- Conditions
- Virtual Reality, Vaccination, Pain, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Sep 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.
Objective: to estimate the effect of virtual reality as a distracting technique against traditional distracting techniques in the vaccination procedure in the pediatric population.
Design: randomized clinical trial. Field of study: the study will be carried out in the field of pediatric primary care nursing consultation, where the pediatric systematic vaccination is performed.
Subjects to study: the sample will be made up of children from 3 to 14 years old who are punctured for immunization in the Fuensanta Health Center that belongs to the Department of Health Valencia-General Hospital.
Variables: age, sex, family country of origin, years living in Spain, number of children of the nuclear family, order in the number of siblings, socioeconomic level, age of the caregiver that accompanies the child, affiliation / bond with the child . Group to which the subject belongs (intervention group vs. control group). Number of punctures received in the last year. Heart rate pre and post vaccination. Type of vaccine. Combination of several punctures in the query. Previous use of virtual reality. Level of pain and fear after puncture. Parent or legal guardian satisfaction.
Data collection: it will be held at the Health Center on the same day as the vaccination prodecure. On the part of the nurse (heart rate, type of vaccine, combination of several punctures), the child (pain, fear) and the parents / legal guardian (satisfaction, sociodemographic).
Data analysis: The descriptive analysis of the quantitative variables will be carried out through the calculation of means, typical deviations, medians, ranges, minimum and maximum values. Qualitative variables will be analyzed in absolute and relative frequencies. For the statistical inference analysis, the T-test analysis of mean difference or U-Mann Whitney (according to normal compliance) will be used. All analyzes will be performed with a 95% confidence interval.
Detailed description
Process:
The health professional responsible for carrying out the intervention will be the nurse of the pediatric consultation of the Health Center where the study will be carried out. She is the only nurse in this center, so she will be the only professional to perform the procedure on all subjects participating in the study; in this way the variability in the puncture technique is avoided.
The nurse will recruit potential participants who meet inclusion criteria, informing about the research and answering their possible questions. Once participants wishing to be part of the study have signed the informed consent, they will be coded by numbers. These numerical codes will be linked chronologically to the random sequence previously generated by the sealedenvelopeTM software. Once the nurse knows the group to which the participant belongs, she will perform the corresponding intervention.
The evaluation after the completion of the vaccination procedure will be carried out through self-administered scales (by the child for pain and fear variables, and by the caregiver for sociodemographic and satisfaction variables). In addition, the nurse will record data regarding vaccinations.
The data collection time is estimated at 1 year and a half or until the sample size is reached.
Intervention:
The study groups will be determined by the randomization of the sample into two groups: GI and GC. The GI will use as a distracting measure the viewing of VR experiences adapted to their age with the Oculus Go VR glasses during the puncture. The GC will use habitual non-virtual distracting measures: being in the arms of the main caregiver or maintaining physical contact with him (for example, shaking hands) and / or playing or watching videos with the mobile phone of the parents or legal guardian.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Virtual Reality GroupParticipants use as a distracting measure Virtual Reality glasses during the vaccination. |
| Control Group | No intervention | –Participants use usual non-virtual distracting measures during the vaccination. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged between 3 and 14 years old, who attend a pediatric nursing office of the Fuensanta Health Center (Valencia) for immunization by vaccine.
- Children who are accompanied by a caregiver (father, mother, legal guardian) during the procedure.
- That both the child and the caregiver understand and speak Spanish.
- That they have consented to participate in the study: in children by verbal consent and in their father, mother, legal guardian, by signing the informed consent document.
Key exclusion criteria (4 listed)
- Children with sensory problems that prevent the use of RV.
- Children with sensory impairment of pain perception (for example, spina bifida).
- Children who have taken analgesic medication on the day of the puncture, either orally or topically in the puncture area.
- Children with a history of seizures or dizziness.
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 Reality GroupParticipants are from 3 to 14 years old who attend a pediatric primarey health care of the Fuensanta Health Center (Valencia) for immunization by vaccine. | Other | Intervention Group |
Primary outcome
Compare the perception of pain in children during the vaccination between participants to recive virtual reality and to recive usual distraction mesures: Wong-Baker FACES scale
Time frame: It is immediately after vaccination.
El dolor es una experiencia emocional y sensorial desagradable, que puede deberse a un procedimiento terapéutico como la vacunación. Para medir el nivel de dolor del niño después de la vacunación, se utilizará la Escala de calificación del dolor: escala FACES de Wong-Baker. Es un cuestionario validado desarrollado por Bieri en 1990. Está indicado para niños entre 3 y 18 años. La escala va de 0 a 10 y tiene 6 caras. A cada cara se le asigna un puntaje. El primero, con un valor de 0, equivale a "no hurt"; la segunda, con un valor de 2 , equivale a "hurts little bit", el tercero, con un valor de 4 es igual a "hurts little more", el cuarto, con un valor de 6, significa "hurts even more", el quinto, con un valor de 8, es igual a "hurts whole lot" y el último, con un valor de 10 es igual a "hurts worse". Se le pide al paciente que seleccione la cara que mejor describa cómo se siente. En el nivel psicométrico, esta escala se valida r = .90, alfa de Cronbach = .93 (Keck, 1996).
1 secondary outcome
Compare the perception of fear in children during the vaccination between participants to recive virtual reality and usual distraction mesures.
Time frame: It is immediately after vaccination.
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 7 Feb 2024.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Background: PubMed 8991337Keck JF, Gerkensmeyer JE, Joyce BA, Schade JG. Reliability and validity of the Faces and Word Descriptor Scales to measure procedural pain. J Pediatr Nurs. 1996 Dec;11(6):368-74. doi: 10.1016/S0882-5963(96)80081-9.
- Background: PubMed 29053848Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
- 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 Virtual Reality Group in people with Virtual Reality and Vaccination, run by Cardenal Herrera University at 1 site 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 4 inclusion and 4 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 7 Feb 2024. 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 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?
Compare the perception of pain in children during the vaccination between participants to recive virtual reality and to recive usual distraction mesures: Wong-Baker FACES scale (time frame: It is immediately after vaccination.). 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 NCT04096833, which also lists 3 linked publications.
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 7 Feb 2024.