PainNCT06112600
The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination
A study testing VR and Kaleidoscope in people with Pain and Pediatric Patient, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Read more about this study
- Who is it for?
- Ages 48 to 48 months
- Conditions the study is for
- Pain, Pediatric Patient, Fear
- What is being tested?
- VR and Kaleidoscope
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 30 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 48 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being 48 months
- being conscious (with the ability to communicate).
Who cannot join
- Having a physical and psychological condition that prevents them from wearing glasses to view VR;
- Having a visual problem
- Having mental or physical disabilities
- Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
- Having chronic or life-threatening disease
- Refusing the VR or kaleidoscope intervention during vaccine injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study
This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.
- Conditions
- Pain, Pediatric Patient, Fear, Virtual Reality, Nursing Caries
- Being tested
- VR, Kaleidoscope
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRProcedure or surgery
Virtual reality glasses were used as a distraction method for children during vaccination.
KaleidoscopeProcedure or surgery
Kaleidoscope toys were used as a distraction method for children during vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No attention-diverting method was applied to the children in this group and routine vaccination was administered. |
| Virtual Reality group | Experimental | The VR group received a VR application using the Oculus Quest 2 while being vaccinated. Receives: Procedure: VR |
| Kaleidoscope group | Experimental | In the Kaleidoscope group, children were given a kaleidoscope toy while being vaccinated. Receives: Procedure: Kaleidoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain
Just before vaccination, both the child and the researcher used the Wong-Baker Faces Scale. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = hurts worst). The child can choose the face that best illustrates the physical pain.
Measured: 1 year
Fear
Just before vaccination, both the child and the researcher used the Children's Fear Scale. The scale includes five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and has been validated for the Turkish population The scale allows for evaluations on a scale from 0 to 4.
Measured: 1 year
Anxiety
Just before vaccination, both the child and the researcher used the Children's Anxiety Meter-State. It is drawn like a thermometer with a bulb at the bottom. It includes horizontal lines going up to the top (0-10). Children are asked to mark how feel "right now" to measure state anxiety. Higher values represent higher anxiety.
Measured: 1 year
Secondary outcomes (1)
Parental satisfaction
parental satisfaction scores measured with the 10-point Likert type scale. Minimum score is 0, maximum score is 10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Sep 2021
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomised controlled study
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gümüş, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112600
- Sponsor's protocol ID
- E-79593712-799
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 1 Nov 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06112600
- Acronym / sponsor ID
- E-79593712-799
- Conditions
- Pain, Pediatric Patient, Fear, Virtual Reality, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Nov 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.
This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This prospective, randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No attention-diverting method was applied to the children in this group and routine vaccination was administered. |
| Virtual Reality group | Experimental | Procedure: VRThe VR group received a VR application using the Oculus Quest 2 while being vaccinated. |
| Kaleidoscope group | Experimental | Procedure: KaleidoscopeIn the Kaleidoscope group, children were given a kaleidoscope toy while being vaccinated. |
Who may qualify
- Ages
- 48 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- being 48 months
- being conscious (with the ability to communicate).
Key exclusion criteria (6 listed)
- Having a physical and psychological condition that prevents them from wearing glasses to view VR;
- Having a visual problem
- Having mental or physical disabilities
- Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
- Having chronic or life-threatening 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 |
|---|---|---|
| VRVirtual reality glasses were used as a distraction method for children during vaccination. | Procedure or surgery | Virtual Reality group |
| KaleidoscopeKaleidoscope toys were used as a distraction method for children during vaccination. | Procedure or surgery | Kaleidoscope group |
Primary outcome
Procedural Pain
Time frame: 1 year
Just before vaccination, both the child and the researcher used the Wong-Baker Faces Scale. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = hurts worst). The child can choose the face that best illustrates the physical pain.
Fear
Time frame: 1 year
Just before vaccination, both the child and the researcher used the Children's Fear Scale. The scale includes five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and has been validated for the Turkish population The scale allows for evaluations on a scale from 0 to 4.
Anxiety
Time frame: 1 year
Just before vaccination, both the child and the researcher used the Children's Anxiety Meter-State. It is drawn like a thermometer with a bulb at the bottom. It includes horizontal lines going up to the top (0-10). Children are asked to mark how feel "right now" to measure state anxiety. Higher values represent higher anxiety.
1 secondary outcome
Parental satisfaction
Time frame: 1 year
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 1 Nov 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.
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 VR and Kaleidoscope in people with Pain and Pediatric Patient, run by Ege University at 1 site in Turkey (Türkiye).
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 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 1 Nov 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 Turkey (Türkiye). 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?
Procedural Pain (time frame: 1 year). The study lists 3 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 1 Nov 2023.