Pediatric Hematology, Pediatric Oncology
Conditions
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 first-attempt success.
Interventions
OTHERPerforming a Hand Puppet to Music
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.
OTHERHand Squeezing Soft Toy (Squishy)
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 cooperation and IV placement success.
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Physical condition preventing use of a squeeze toy. Cognitive or developmental disorders preventing understanding of procedural instructions. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration | During procedure | Time from start to successful IV catheter placement. |
| Number of IV catheter attempts: | During the IV procedure | Recorded for each peripheral IV catheter placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Fear Scale | Measured before and immediately after IV catheter placement | 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 | During procedure | 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. |
Contacts
CONTACTMeltem Gürcan, PhD
Outcome results
None listed