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

NCT06856395 | Not Yet Recruiting

• 1 other identifier: 0000-0003-1227-5856
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fear; Fear of Pain; Pain; Vaccination; Child Behavior

Keywords

pain; fear; vaccination; child behavior

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (2)

• Fear status of participants in the experimental group post vaccination

  6 months

• Children fear status of participants in the control group post vaccination

  6 months

Study Arms (2)

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.

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.

Interventions

intervention group OTHER

Robotic distraction during vaccination process

intervention group

Eligibility Criteria

• Age: 48 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead

MeSH Terms

Conditions

Pain; Child Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Randomized controlled trial with 2 groups

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 4, 2025
• Study Start: March 31, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03