Social Robot Interaction on Fear and Pain Levels in Children (NCT07632625) | Clinical Trial Compass
CompletedNot Applicable
Social Robot Interaction on Fear and Pain Levels in Children
Turkey (Türkiye)90 participantsStarted 2025-12-21
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a social robot interaction to help children during painful procedures — based on the results, does the evidence suggest this kind of distraction technique is something our care team could realistically use for my child's upcoming procedures?
2The trial measured pain using the Wong-Baker Faces Pain Rating Scale and fear using the Children Fear Scale — what did the findings actually show, and were the reductions in pain or fear scores meaningful enough to make a practical difference for kids in similar situations?
3Since this trial is already completed, are the results published or available anywhere, and would you be willing to review them with me to see if the approach fits my child's specific age, temperament, and type of procedure?
4Even without a social robot, are there other non-medication distraction or anxiety-reduction strategies your team already uses during pediatric procedures that are backed by similar evidence?
5If my child struggles significantly with fear or pain during procedures, would it be worth asking the facility whether any robot-assisted distraction programs are currently in use, based on what trials like this one have found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wong-Baker Faces Pain Rating Scale
Timeframe: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
2
Children Fear Scale
Timeframe: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.