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NCT Number: NCT06856395

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

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.

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Key information

Conditions

Fear Behavior Child Behavior Fear of Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vaccination

Age range

48 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group

Other

Robotic distraction during vaccination process

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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