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

March 6, 2025 updated by: Sibel Ergün, Balikesir University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Robotic distraction during vaccination process
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear status of participants in the experimental group post vaccination
Time Frame: 6 months
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.
6 months
Children fear status of participants in the control group post vaccination
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0000-0003-1227-5856

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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