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Completed
NCT07632625
Social Robot Interaction on Fear and Pain Levels in Children
Conditions: Procedural Pain, Procedural Fear
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 90
Sponsor: Trakya University
Location: Koç University Istanbul Istanbul
Summary
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
* Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
* Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
* Be randomly assigned to one of three groups: social robot, digital game, or standard care.
* Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
* Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
* Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
Eligibility Criteria
Inclusion Criteria:
* Children aged 4-12 years
* Clinical indication for venous blood sampling
* Ability to communicate in Turkish
* No cognitive disabilities
* No sensory disabilities
* Parent or legal guardian provides informed consent
* Child provides verbal assent
Exclusion Criteria:
* Requirement for emergency medical intervention
* Use of analgesic medication within 6 hours prior to the procedure
* Diagnosis of developmental delay
* Previous participation in a social robot-based intervention or study
Source: ClinicalTrials.gov (NCT07632625). StuddyBuddy aggregates publicly available trial information.