PainNCT06443060
The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children
A study testing Virtual Reality Group and Buzzy Application Group in people with Pain and Fear, run by KTO Karatay University.
Trial summary
Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- What is being tested?
- Virtual Reality Group and Buzzy Application Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be between the ages of 7-10
- It will be the first time that a prick test will be applied.
- The child can speak and understand Turkish comfortably
- He and his family agree to participate in the study.
- Not having used analgesic medication at least six hours ago
Who cannot join
- The child has any diagnosed psychiatric disorder
- Having visual, auditory or speech disorders
- Having a chronic disease other than allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children: Randomized Controlled Study
Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment. When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
Read the detailed description
Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment.
When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
- Conditions
- Pain, Fear, Anxiety, Children, Only, Virtual Reality
- Being tested
- Virtual Reality Group, Buzzy Application Group, Control Group
- Keywords
- BUZZY, Virtual Reality, Pain, Fear, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupBehavioural
Before starting the Prick procedure, the child in the virtual reality group, which is determined by randomisation, will be given a brief information about how the allergy test will be performed and about virtual reality. Before the Prick test (approximately 2 minutes before the Prick test), the child will start to watch a film deemed appropriate by the experts by wearing virtual reality and headphones. After the child starts watching the film, the child will be asked to extend his/her left arm and solutions will be dripped on the forearm and the puncture will be performed with a lancet. The child will continue to watch the film during the whole procedure.
Buzzy Application GroupBehavioural
Before starting the prick procedure, the child in the buzzy group, which was determined by randomisation, will be given a brief information about how the allergy test will be performed and the buzzy device. The children in the buzzy experimental group will be connected to the buzzy cold and vibration device at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) 5-10 seconds before starting the procedure and the prick test application will be started.
Control GroupOther
Before starting the prick procedure, the children in the control group determined by randomisation will be given routine explanations according to the outpatient clinic procedure before starting the procedure and the prick test will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | After the scales are filled in, the child will be shown a cartoon film deemed appropriate by the experts by wearing VR glasses and headphones before the Prick test (average 2 minutes). The appropriate cartoon will be shown to the VR glasses group for an average of 15 minutes. After the child starts watching the cartoon, the child will be asked to extend his/her left arm and the prick test process will begin. Receives: Behavioral: Virtual Reality Group |
| Buzzy Application Group | Experimental | The CFS-D scale will be completed only by the child to measure the anxiety level before the procedure. To assess pain and fear, the WB-FACES pain scale and the CFS fear scale will be completed by the child, parent and researcher before the procedure. The buzzy cold and vibration device will be connected to the children in the buzzy experimental group 5-10 seconds before the procedure, at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) and the prick test application will be started. Receives: Behavioral: Buzzy Application Group |
| Control Group | Active comparator | Children in this group will be given routine explanations according to the outpatient clinic procedure and prick test will be applied before the procedure. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Child Anxiety Scale-Stability Scale (CAS-D)
The Child Anxiety Scale-Stability Scale (CAS-D); is shaped like a thermometer with a light bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children are instructed to 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer'. A transparent metre is placed over the child's rating on which ½ point increments are marked, then the ½ point increment is rounded up to the nearest number. The score can range from 0-10. Above 5 points indicates high anxiety. The CVI is 0.89, the correlation coefficient is 0.99.
Measured: six month
Child Fear Scale (CFS)
Child Fear Scale; This scale assesses pain-related fear in children. The Child Fear Scale (CFS) developed by McMurty et al. (2011) is a scale suitable for the 5-10 age group and consists of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). It can be easily assessed by researchers and health professionals who provide care/intervention to children (McMurtry et al., 2011). There is no gold standard self-report scale that assesses fear for children. Test-retest method was used in the validity study of the scale. The Turkish version of the scale was adapted by Özalp Gerçeker et al. (2018) and the Content Validity Index (CVI) was found to be 0.89 and the correlation coefficient was 0.96 (Özalp Gerçeker et al., 2018).
Measured: six month
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Wong-Baker FACES Pain Rating Scale (WB-FACES); It was developed by Wong and Baker in 1981 and revised in 1983. It is used to diagnose pain in children and adolescents aged 3-18 years. This scale, which can be used safely over the age of three, consists of six facial parts scored between 0-10. The face shape representing no pain is evaluated as 0 points and the face shape representing severe pain is evaluated as 10 points. Participants are asked to choose the best facial expression that best describes them. WB_FACES is a scale suitable for use in Turkey (Sahiner \& Bal, 2015) and will be evaluated by the parents and the researcher as well as the child's self-report in this study.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start15 Oct 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine Geçkil, Principal investigator, Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443060
- Sponsor's protocol ID
- FundaTEZ
- Status last verified
- Sep 2025
- First submitted
- 16 May 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is over
Publications
Gurbuz F, Geckil E, Guner SN. The effect of virtual reality and buzzy(R) on pain, fear, and anxiety during skin prick testing in children: a randomized controlled trial. Eur J Pediatr. 2026 May 5;185(6):349. doi: 10.1007/s00431-026-07020-3.
PubMed 42086773
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06443060
- Acronym / sponsor ID
- FundaTEZ
- Conditions
- Pain, Fear, Anxiety, Children, Only, Virtual Reality
- Keywords
- BUZZY, Virtual Reality, Pain, Fear, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Jun 2024 (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.
Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment. When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
Detailed description
Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.
Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment.
When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual Reality GroupAfter the scales are filled in, the child will be shown a cartoon film deemed appropriate by the experts by wearing VR glasses and headphones before the Prick test (average 2 minutes). The appropriate cartoon will be shown to the VR glasses group for an average of 15 minutes. After the child starts watching the cartoon, the child will be asked to extend his/her left arm and the prick test process will begin. |
| Buzzy Application Group | Experimental | Behavioral: Buzzy Application GroupThe CFS-D scale will be completed only by the child to measure the anxiety level before the procedure. To assess pain and fear, the WB-FACES pain scale and the CFS fear scale will be completed by the child, parent and researcher before the procedure. The buzzy cold and vibration device will be connected to the children in the buzzy experimental group 5-10 seconds before the procedure, at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) and the prick test application will be started. |
| Control Group | Active comparator | Other: Control GroupChildren in this group will be given routine explanations according to the outpatient clinic procedure and prick test will be applied before the procedure. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child must be between the ages of 7-10
- It will be the first time that a prick test will be applied.
- The child can speak and understand Turkish comfortably
- He and his family agree to participate in the study.
- Not having used analgesic medication at least six hours ago
Key exclusion criteria (3 listed)
- The child has any diagnosed psychiatric disorder
- Having visual, auditory or speech disorders
- Having a chronic disease other than allergy
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 GroupBefore starting the Prick procedure, the child in the virtual reality group, which is determined by randomisation, will be given a brief information about how the allergy test will be performed and about virtual reality. Before the Prick test (approximately 2 minutes before the Prick test), the child will start to watch a film deemed appropriate by the experts by wearing virtual reality and headphones. After the child starts watching the film, the child will be asked to extend his/her left arm and solutions will be dripped on the forearm and the puncture will be performed with a lancet. The child will continue to watch the film during the whole procedure. | Behavioural | Virtual Reality Group |
| Buzzy Application GroupBefore starting the prick procedure, the child in the buzzy group, which was determined by randomisation, will be given a brief information about how the allergy test will be performed and the buzzy device. The children in the buzzy experimental group will be connected to the buzzy cold and vibration device at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) 5-10 seconds before starting the procedure and the prick test application will be started. | Behavioural | Buzzy Application Group |
| Control GroupBefore starting the prick procedure, the children in the control group determined by randomisation will be given routine explanations according to the outpatient clinic procedure before starting the procedure and the prick test will be applied. | Other | Control Group |
Primary outcome
The Child Anxiety Scale-Stability Scale (CAS-D)
Time frame: six month
The Child Anxiety Scale-Stability Scale (CAS-D); is shaped like a thermometer with a light bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children are instructed to 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer'. A transparent metre is placed over the child's rating on which ½ point increments are marked, then the ½ point increment is rounded up to the nearest number. The score can range from 0-10. Above 5 points indicates high anxiety. The CVI is 0.89, the correlation coefficient is 0.99.
Child Fear Scale (CFS)
Time frame: six month
Child Fear Scale; This scale assesses pain-related fear in children. The Child Fear Scale (CFS) developed by McMurty et al. (2011) is a scale suitable for the 5-10 age group and consists of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). It can be easily assessed by researchers and health professionals who provide care/intervention to children (McMurtry et al., 2011). There is no gold standard self-report scale that assesses fear for children. Test-retest method was used in the validity study of the scale. The Turkish version of the scale was adapted by Özalp Gerçeker et al. (2018) and the Content Validity Index (CVI) was found to be 0.89 and the correlation coefficient was 0.96 (Özalp Gerçeker et al., 2018).
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Time frame: six month
Wong-Baker FACES Pain Rating Scale (WB-FACES); It was developed by Wong and Baker in 1981 and revised in 1983. It is used to diagnose pain in children and adolescents aged 3-18 years. This scale, which can be used safely over the age of three, consists of six facial parts scored between 0-10. The face shape representing no pain is evaluated as 0 points and the face shape representing severe pain is evaluated as 10 points. Participants are asked to choose the best facial expression that best describes them. WB_FACES is a scale suitable for use in Turkey (Sahiner \& Bal, 2015) and will be evaluated by the parents and the researcher as well as the child's self-report in this study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 42086773Gurbuz F, Geckil E, Guner SN. The effect of virtual reality and buzzy(R) on pain, fear, and anxiety during skin prick testing in children: a randomized controlled trial. Eur J Pediatr. 2026 May 5;185(6):349. doi: 10.1007/s00431-026-07020-3.
- Individual participant dataSharing planned: No. After the research is over
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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.
Emine Geçkil principal investigator
Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Group and Buzzy Application Group in people with Pain and Fear, run by KTO Karatay University.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Funda Gürbüz (05065005321 ext. 7522, fundakaya033@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Child Anxiety Scale-Stability Scale (CAS-D) (time frame: six month). 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?
On the ClinicalTrials.gov record for NCT06443060, 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 17 Sep 2025.