FearNCT06856395
Effect of Using Educational Robots During Vaccination on Fear and Pain in Children
A study testing intervention group in people with Fear and Fear of Pain, run by Balikesir University.
Trial summary
Pain and fear are very common in children during vaccination. We are planning to conduct a study to help children go through this process more comfortably. The aim is to examine whether the educational robot has an effect on pain and fear during vaccination in 4-year-old children in a randomized controlled manner. Read more about this study
- Who is it for?
- Ages 48 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Fear, Fear of Pain, Pain
- What is being tested?
- intervention group
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 31 Jan 2026
- 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 48 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteering to participate in the study
- The child must be 4 years old
- Must have come to a primary care center in Balıkesir city center
- DaBT-İPA vaccination must be administered
- Vastus Lateralis muscle must be used in vaccination
Who cannot join
- Not volunteering to participate in the study
- The child is not 4 years old
- He/she has not come to a family health center in Balıkesir city center
- DaBT-İPA vaccination is not applied
- Vastus Lateralis muscle will not be used in vaccination application
About this study
Pain and fear are very common in children during vaccination. We are planning to conduct a study to help children go through this process more comfortably. The aim is to examine whether the educational robot has an effect on pain and fear during vaccination in 4-year-old children in a randomized controlled manner.
Read the detailed description
Data Collection Method:
A sample group of 74 people will be divided into two groups using www.randomizer.org using a simple randomization method.
Intervention group: The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-IPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will prepare the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-IPA vaccination process. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. Control Group: After the procedure is explained according to the child's developmental level, the DaBT-İPA vaccine will be administered in accordance with the institution's policies. 5 minutes later, the Sociodemographic data form, Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. At the end of the data collection, the control group will be provided with the opportunity to spend time with the robot in order to be beneficial.
- Conditions
- Fear, Fear of Pain, Pain, Vaccination, Child Behavior
- Being tested
- intervention group
- Keywords
- pain, fear, vaccination, child behavior
- Medical subject headings
- Pain, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
Robotic distraction during vaccination process
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-İPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will be prepared for the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-İPA vaccination procedure. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using the face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. Receives: Other: intervention group |
| control group | No intervention | After the procedure is explained according to the child's developmental level, the DaBT-IPA vaccine will be administered in accordance with the institution's policies. After 5 minutes, the Sociodemographic data form, Child Fear Scale (CHS), Wong Baker Pain Scale will be filled out by the researcher using the face-to-face interview technique. At the end of the data collection, the control group will be provided with time to spend with the robot in order to be beneficial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain status of participants in the experimental group post vaccination
Average pain scale score of participants in the experimental group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.
Measured: 6 months
Pain status of participants in the control group post vaccination
Average pain scale score of participants in the control group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.
Measured: 6 months
Secondary outcomes (2)
Fear status of participants in the experimental group post vaccination
Average children fear scale score of participants in the experimental group after vaccination.In the children's fear scale, the lowest value is expressed as 0 and the highest value is expressed as 4.
Measured: 6 months
Children fear status of participants in the control group post vaccination
Average children fear scale score of participants in the control group after vaccination.In the children's fear scale, the lowest value is expressed as 0 and the highest value is expressed as 4.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Ergün, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856395
- Sponsor's protocol ID
- 0000-0003-1227-5856
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2025
- Last updated
- 11 Mar 2025
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Educational Robots During Vaccination on Fear and Pain in Children
- ClinicalTrials.gov ID
- NCT06856395
- Acronym / sponsor ID
- 0000-0003-1227-5856
- Conditions
- Fear, Fear of Pain, Pain, Vaccination, Child Behavior
- Keywords
- pain, fear, vaccination, child behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Mar 2025 (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.
Pain and fear are very common in children during vaccination. We are planning to conduct a study to help children go through this process more comfortably. The aim is to examine whether the educational robot has an effect on pain and fear during vaccination in 4-year-old children in a randomized controlled manner.
Detailed description
Data Collection Method:
A sample group of 74 people will be divided into two groups using www.randomizer.org using a simple randomization method.
Intervention group: The child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-IPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will prepare the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-IPA vaccination process. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. Control Group: After the procedure is explained according to the child's developmental level, the DaBT-İPA vaccine will be administered in accordance with the institution's policies. 5 minutes later, the Sociodemographic data form, Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using a face-to-face interview technique. At the end of the data collection, the control group will be provided with the opportunity to spend time with the robot in order to be beneficial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 groups
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: intervention groupThe child patients in this group will be given the opportunity to get to know, touch and examine the educational mini robot for 5 minutes before the DaBT-İPA vaccination. The robot will attract the child's attention. During this time, the sociodemographic data form will be filled. At the end of the 5th minute, the child patient will be prepared for the vaccination with the cooperation of the staff and parents. During this time, the researcher will maintain the child's relationship with the robot and ensure that he/she focuses his/her attention on the robot. The application will end after the DaBT-İPA vaccination procedure. 5 minutes after the procedure, the Child Fear Scale (ÇKÖ, Wong Baker Pain Scale) will be filled by the researcher using the face-to-face interview technique. The robot will be cleaned with antiseptic solution after each child patient. |
| control group | No intervention | –After the procedure is explained according to the child's developmental level, the DaBT-IPA vaccine will be administered in accordance with the institution's policies. After 5 minutes, the Sociodemographic data form, Child Fear Scale (CHS), Wong Baker Pain Scale will be filled out by the researcher using the face-to-face interview technique. At the end of the data collection, the control group will be provided with time to spend with the robot in order to be beneficial. |
Who may qualify
- Ages
- 48 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Volunteering to participate in the study
- The child must be 4 years old
- Must have come to a primary care center in Balıkesir city center
- DaBT-İPA vaccination must be administered
- Vastus Lateralis muscle must be used in vaccination
Key exclusion criteria (5 listed)
- Not volunteering to participate in the study
- The child is not 4 years old
- He/she has not come to a family health center in Balıkesir city center
- DaBT-İPA vaccination is not applied
- Vastus Lateralis muscle will not be used in vaccination application
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 |
|---|---|---|
| intervention groupRobotic distraction during vaccination process | Other | intervention group |
Primary outcome
Pain status of participants in the experimental group post vaccination
Time frame: 6 months
Average pain scale score of participants in the experimental group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.
Pain status of participants in the control group post vaccination
Time frame: 6 months
Average pain scale score of participants in the control group after vaccination. In the Wong Baker pain scale, the lowest value is expressed as 0 and the highest value is expressed as 5.
2 secondary outcomes
Fear status of participants in the experimental group post vaccination
Time frame: 6 months
Children fear status of participants in the control group post vaccination
Time frame: 6 months
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 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Fear and Fear of Pain, run by Balikesir 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 5 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 11 Mar 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?
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?
Pain status of participants in the experimental group post vaccination (time frame: 6 months). 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 11 Mar 2025.