VaccinationNCT06686992
The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration
A study testing Vaccination in people with Vaccination, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted to examine the effect of distraction method on children's pain and fear levels during vaccine administration. The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. Read more about this study
- Who is it for?
- Ages 4 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 12 Mar 2025
- 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 4 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being 4 years old
- Not having a disability related to developmental areas
- The mother or father should be with the child during the procedure
Who cannot join
- being older or younger than 4 years old
- having a chronic disease
- lack of willingness to work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, 25240
About this study
Official title: The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration: a Randomized Controlled Trial
The study will be conducted to examine the effect of distraction method on children's pain and fear levels during vaccine administration. The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
Read the detailed description
The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
Round and Draw game: The game designed by the researcher will be used as the intervention tool in the study. The game is played by creating a face picture by drawing the corresponding sections with the help of a dice consisting of 6x5 sections. With the game, it is planned to minimize pain and fear in children during vaccination. Care will be taken to ensure that the materials to be used are appropriate for the developmental level of the children, easy to clean and do not develop any allergies in children.
Data Collection The researcher will be present in the centers where the study will be conducted for 1 day to examine the ergonomic structure of the pediatric family health centers before starting to collect the data of the play group and control group children. The children and their parents will be given preliminary information about the research (the purpose of the research, why the research is being conducted, the use of the roll-and-draw game in relieving the child's pain and fear, etc.), and after obtaining verbal consent from the children and written consent from the parents, the data of the research will be obtained by face-to-face interview method with the children who agree to participate in the research.
Control Group: The questionnaires and scales will be filled in by the researcher 5 minutes before the vaccination process. Only routine 4-year-old vaccines will be administered. The scales will be filled out again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
Interventıon Group: The questionnaire and scales will be filled out by the researcher 5 minutes before vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
- Conditions
- Vaccination
- Being tested
- Vaccination
- Keywords
- pain, fear, vaccine, nursing, distraction, child
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBehavioural
The researcher will fill in the questionnaire and scales 5 minutes before the vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
| Study group | Role | What they receive |
|---|---|---|
| distraction | Experimental | The researcher will fill in the questionnaire and scales 5 minutes before the vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms. Receives: Behavioral: Vaccination |
| control | No intervention | Questionnaires and scales will be filled out by the researcher 5 minutes before vaccination. Only routine applications will be made. The scales will be filled again 5 minutes after vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Rating Scale (WB-FRAS)
This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six faces representing increasing pain intensity from zero to five from left to right. The leftmost face has a smiling expression, indicating a pain-free state, while the rightmost face has a crying expression, corresponding to the most severe pain. The child is instructed to choose the face that best expresses their own emotions. Six facial expressions are scored from left to right from 0 to 5 points (0 points= very happy/no pain, 5 points= most severe pain). As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.
Measured: 1 months
Child Fear Scale
The Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 scale with five faces ranging from neutral (0 = no concern at all) to fearful (4 = severe concern).
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Nov 2024
- Primary completion28 Feb 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686992
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/134
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06686992
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/134
- Conditions
- Vaccination
- Keywords
- pain, fear, vaccine, nursing, distraction, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 13 Nov 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.
The study will be conducted to examine the effect of distraction method on children's pain and fear levels during vaccine administration. The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
Detailed description
The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
Round and Draw game: The game designed by the researcher will be used as the intervention tool in the study. The game is played by creating a face picture by drawing the corresponding sections with the help of a dice consisting of 6x5 sections. With the game, it is planned to minimize pain and fear in children during vaccination. Care will be taken to ensure that the materials to be used are appropriate for the developmental level of the children, easy to clean and do not develop any allergies in children.
Data Collection The researcher will be present in the centers where the study will be conducted for 1 day to examine the ergonomic structure of the pediatric family health centers before starting to collect the data of the play group and control group children. The children and their parents will be given preliminary information about the research (the purpose of the research, why the research is being conducted, the use of the roll-and-draw game in relieving the child's pain and fear, etc.), and after obtaining verbal consent from the children and written consent from the parents, the data of the research will be obtained by face-to-face interview method with the children who agree to participate in the research.
Control Group: The questionnaires and scales will be filled in by the researcher 5 minutes before the vaccination process. Only routine 4-year-old vaccines will be administered. The scales will be filled out again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
Interventıon Group: The questionnaire and scales will be filled out by the researcher 5 minutes before vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| distraction | Experimental | Behavioral: VaccinationThe researcher will fill in the questionnaire and scales 5 minutes before the vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms. |
| control | No intervention | –Questionnaires and scales will be filled out by the researcher 5 minutes before vaccination. Only routine applications will be made. The scales will be filled again 5 minutes after vaccination. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being 4 years old
- Not having a disability related to developmental areas
- The mother or father should be with the child during the procedure
Key exclusion criteria (3 listed)
- being older or younger than 4 years old
- having a chronic disease
- lack of willingness to work
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 |
|---|---|---|
| VaccinationThe researcher will fill in the questionnaire and scales 5 minutes before the vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms. | Behavioural | distraction |
Primary outcome
Wong-Baker Facial Expression Rating Scale (WB-FRAS)
Time frame: 1 months
This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six faces representing increasing pain intensity from zero to five from left to right. The leftmost face has a smiling expression, indicating a pain-free state, while the rightmost face has a crying expression, corresponding to the most severe pain. The child is instructed to choose the face that best expresses their own emotions. Six facial expressions are scored from left to right from 0 to 5 points (0 points= very happy/no pain, 5 points= most severe pain). As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.
Child Fear Scale
Time frame: 1 months
The Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 scale with five faces ranging from neutral (0 = no concern at all) to fearful (4 = severe concern).
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 17 Mar 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Vaccination in people with Vaccination, run by Ataturk 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 3 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: finished, as of the sponsor's last update on 17 Mar 2025. 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?
Wong-Baker Facial Expression Rating Scale (WB-FRAS) (time frame: 1 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 17 Mar 2025.