Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients

N/ANot Yet RecruitingNCT07493018

Akdeniz University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pediatric Hematology Pediatric Oncology

Interventions

Performing a Hand Puppet to MusicOTHER

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.

Hand Squeezing Soft Toy (Squishy)OTHER

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

Procedure duration

Time from start to successful IV catheter placement.

Time frame: During procedure

Number of IV catheter attempts:

Recorded for each peripheral IV catheter placement.

Time frame: During the IV procedure

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.

Time frame: 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.

Time frame: During procedure

Central Contacts

Meltem Gürcan, PhD

CONTACT

+90 506 508 6214 meltemgurcan32@gmail.com

Data from ClinicalTrials.gov

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