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Clinical Trial NCT07493018 for Pediatric Hematology, Pediatric Oncology is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients 90 Randomized Pediatric
Clinical Trial NCT07493018 is an interventional study for Pediatric Hematology, Pediatric Oncology and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 90 participants. Led by Akdeniz University, this study is expected to complete by 1 October 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and f...Show More
Official Title
The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial
Conditions
Pediatric HematologyPediatric OncologyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- AkdenizUnOncology
NCT ID Number
Start Date (Actual)
2026-05
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-10
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHand Puppet In this arm, an independent researcher will use a hand puppet with child-friendly animal or profession-themed designs, moving it to music during IV catheter placement to engage the child's attention. The child selects the puppet and interacts with it while another researcher collects data. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. | Hand Puppet Children interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress. |
ExperimentalSqueeze Toy Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. | Squeeze Toy Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve co...Show More |
No InterventionControl Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Procedure duration | Time from start to successful IV catheter placement. | During procedure |
Number of IV catheter attempts: | Recorded for each peripheral IV catheter placement. | During the IV procedure |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Children's Fear Scale | A 5-point visual scale (0 = no fear, 4 = extreme fear) measuring children's anxiety and fear before and after the procedure. Applicable for children aged 5-10, can be completed by the child or observer. | Measured before and immediately after IV catheter placement |
Children's Emotional Manifestation Scale | Observational tool evaluating emotional responses during stressful medical procedures across five categories (facial expression, vocalization, activity, interaction, cooperation). Each category scored 1-5; total score 5-25, with higher scores indicating more negative emotional responses. | During procedure |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
Children aged 6-10 years with a pediatric hematology or oncology diagnosis.
Cognitively able to understand instructions during the procedure.
Require peripheral IV catheter placement as determined by the healthcare team.
Difficult Intravenous Access (DIVA) Score ≥4.
Child and parent/guardian willing to participate.
Physical condition preventing use of a squeeze toy.
Cognitive or developmental disorders preventing understanding of procedural instructions.
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Akdeniz UniversityStudy Responsible Party
Meltem Gürcan, Principal Investigator, PhD, Research Assistant, Akdeniz University
Study Central Contact
Contact: Meltem Gürcan, PhD, +90 506 508 6214, [email protected]
No location data.