Anxiety and FearNCT04755998
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations
A study testing Use of virtual reality glasses during vaccination applications in children in people with Anxiety and Fear, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations. Research Hypotheses: Hypothesis 0a (H0a): There is no difference in fear scores between the experimental group in which virtual reality… Read more about this study
- Who is it for?
- Ages 72 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Use of virtual reality glasses during vaccination applications in children
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Dec 2019
- 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 72 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental consent
- Student's willingness to participate in the research
- The student does not have a mental or neurological disability
- Not being able to communicate
- The student does not have a chronic illness
- The student does not have an illness that causes acute or chronic pain
- The student has not used any analgesic medication in the last 24 hours.
Who cannot join
- Lack of parental consent
- Student's unwillingness to participate in the research
- The student has a mental or neurological disability
- The student has a communication disability
- The student has a chronic illness
- The student has an illness that causes acute or chronic pain
- The student's use of medication that will have an analgesic effect in the last 24 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE
Ordu
About this study
Official title: Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels
This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations.
Research Hypotheses:
Read more
Hypothesis 0a (H0a): There is no difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 1a (H1a): There is a difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 0b (H0b): There is no difference in anxiety scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 1b (H1b): There is a difference in anxiety scores experienced between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Read the detailed description
Interventions made for protecting health or curing diseases, significantly affect children's psychological state and social adaptation. Being one of these interventions, vaccination may cause fear and anxiety in children. This fear and anxiety may affect children's future treatment and care experiences and result in fright and avoidance in them. Thus, it is important to try and reduce biological stress and to cope with psychosocial stress. One of the methods which can be used for this purpose is virtual reality headset used as a distraction method. This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations. The population of the study consisted of first grade students attending primary schools in the city center of Ordu. The study was completed with 84 students in the experimental group and 85 students in the control group. With the sample number obtained as a result of the study, the test power was found to be 89.8% when the alpha error was 0.05 and the effect size was kept at 0.5. The data were collected using the Child and Parent Introductory Information Form, Children's Fear Scale, and Children's Anxiety Scale-State Scale.
- Conditions
- Anxiety and Fear
- Being tested
- Use of virtual reality glasses during vaccination applications in children
- Keywords
- Anxiety, Child, Fear, Vaccine, Virtual reality headset
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of virtual reality glasses during vaccination applications in childrenOther
To the experimental group:
Before the vaccine administration;
- Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student.
- Cartoons and virtual reality glasses that the student wanted to watch were prepared.
- While the nurse was preparing the vaccines, the student was put on virtual reality glasses and the distance settings of the lenses were adjusted and the cartoons he chose to watch during the vaccination applications started to be shown. Since virtual reality glasses can cause anxiety attacks manifested by nausea in some children, this was also tested beforehand. It took about two minutes to administer the vaccine and watch cartoons.
Those applied after the vaccine administration;
- Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The Experimental Group watched cartoons with virtual reality glasses during vaccination applications. Receives: Other: Use of virtual reality glasses during vaccination applications in children |
| Control Group | No intervention | Pre-test and post-tests were applied to the non-intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Child Fear Scale
This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. It can be used for children aged 5-10 years.
Measured: with an average interval of three to five minutes
The Children's Anxiety Scale-State Scale
It assesses children's anxiety in clinical settings and uses before medical procedures. The Children's Anxiety Scale-State Scale is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.
Measured: with an average interval of three to five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur KAHRİMAN, Karadeniz Technical University
- Investigators
- İlknur KAHRİMAN, Assoc. Prof., Study director, Karadeniz Technical UniversityZila Ö KIRBAŞ, Master, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755998
- Sponsor's protocol ID
- İlknur KAHRİMAN
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels
- ClinicalTrials.gov ID
- NCT04755998
- Acronym / sponsor ID
- İlknur KAHRİMAN
- Conditions
- Anxiety and Fear
- Keywords
- Anxiety, Child, Fear, Vaccine, Virtual reality headset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Feb 2021 (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 conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations.
Research Hypotheses:
Hypothesis 0a (H0a): There is no difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 1a (H1a): There is a difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 0b (H0b): There is no difference in anxiety scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Hypothesis 1b (H1b): There is a difference in anxiety scores experienced between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.
Detailed description
Interventions made for protecting health or curing diseases, significantly affect children's psychological state and social adaptation. Being one of these interventions, vaccination may cause fear and anxiety in children. This fear and anxiety may affect children's future treatment and care experiences and result in fright and avoidance in them. Thus, it is important to try and reduce biological stress and to cope with psychosocial stress. One of the methods which can be used for this purpose is virtual reality headset used as a distraction method. This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations. The population of the study consisted of first grade students attending primary schools in the city center of Ordu. The study was completed with 84 students in the experimental group and 85 students in the control group. With the sample number obtained as a result of the study, the test power was found to be 89.8% when the alpha error was 0.05 and the effect size was kept at 0.5. The data were collected using the Child and Parent Introductory Information Form, Children's Fear Scale, and Children's Anxiety Scale-State Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Use of virtual reality glasses during vaccination applications in childrenThe Experimental Group watched cartoons with virtual reality glasses during vaccination applications. |
| Control Group | No intervention | –Pre-test and post-tests were applied to the non-intervention group |
Who may qualify
- Ages
- 72 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parental consent
- Student's willingness to participate in the research
- The student does not have a mental or neurological disability
- Not being able to communicate
- The student does not have a chronic illness
Key exclusion criteria (7 listed)
- Lack of parental consent
- Student's unwillingness to participate in the research
- The student has a mental or neurological disability
- The student has a communication disability
- The student has a chronic illness
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 |
|---|---|---|
| Use of virtual reality glasses during vaccination applications in childrenTo the experimental group: Before the vaccine administration; * Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student. * Cartoons and virtual reality glasses that the student wanted to watch were prepared. * While the nurse was preparing the vaccines, the student was put on virtual reality glasses and the distance settings of the lenses were adjusted and the cartoons he chose to watch during the vaccination applications started to be shown. Since virtual reality glasses can cause anxiety attacks manifested by nausea in some children, this was also tested beforehand. It took about two minutes to administer the vaccine and watch cartoons. Those applied after the vaccine administration; - Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student. | Other | Experimental Group |
Primary outcome
The Child Fear Scale
Time frame: with an average interval of three to five minutes
This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. It can be used for children aged 5-10 years.
The Children's Anxiety Scale-State Scale
Time frame: with an average interval of three to five minutes
It assesses children's anxiety in clinical settings and uses before medical procedures. The Children's Anxiety Scale-State Scale is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.
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 16 Feb 2021.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
İlknur KAHRİMAN, Assoc. Prof. study director
Karadeniz Technical University
Zila Ö KIRBAŞ, Master principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of virtual reality glasses during vaccination applications in children in people with Anxiety and Fear, run by Karadeniz Technical 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 7 inclusion and 7 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 16 Feb 2021. 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?
The Child Fear Scale (time frame: with an average interval of three to five minutes). 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 16 Feb 2021.