About this trial
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 first-attempt success.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Performing a Hand Puppet to Music
Other interventionChildren 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.
Hand Squeezing Soft Toy (Squishy)
Other interventionChildren 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 cooperation and IV placement success.
Treatment groups
Trial outcomes
Primary outcomes
Procedure duration
Time from start to successful IV catheter placement.
Number of IV catheter attempts:
Recorded for each peripheral IV catheter placement.
Secondary outcomes
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: