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Not yet recruitingNCT06856395Updated Mar 11, 2025

Effect of Using Educational Robots During Vaccination on Fear and Pain in Children

An interventional study of intervention group in Fear, Fear of Pain and Pain, sponsored by Balikesir University. Not yet recruiting. Open to participants aged 48 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Balikesir University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
48 Months to 60 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Fear
  • Fear of Pain
  • Pain
  • Vaccination
  • Child Behavior

Keywords

  • pain
  • fear
  • vaccination
  • child behavior
03

In context

Lead sponsor

Balikesir University is the lead sponsor of 57 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    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-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.

    Other: intervention group

  • No intervention
    control group

    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.

Interventions

  • Otherintervention group

    Robotic distraction during vaccination process

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06856395
Lead sponsor
Balikesir University
Responsible party
Sibel Ergün (professor, Balikesir University) — Principal investigator
First posted
Mar 4, 2025
Start date
Mar 31, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Mar 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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