Clinical trial NCT06856395: Effect of Using Educational Robots During Vaccination on Fear and Pain in Children
Official title: Effect of Using Educational Robots During Vaccination on Fear and Pain in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fear
Fear of Pain
Pain
Vaccination
Child Behavior
Keywords: pain
fear
vaccination
child behavior
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 74
Sex: ALL
Minimum age (years): 48
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 groups
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain status of participants in the experimental group post vaccination
timeFrame: 6 months
measure: Pain status of participants in the control group post vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Fear status of participants in the experimental group post vaccination
timeFrame: 6 months
measure: Children fear status of participants in the control group post vaccination
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: