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

NCT ID: NCT06856395

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-01-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

intervention group

Intervention Type: OTHER

Robotic distraction during vaccination process

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

intervention group

Robotic distraction during vaccination process

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

Sibel Ergün

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0000-0003-1227-5856

Identifier Type: -

Identifier Source: org_study_id