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NCT Number: NCT07493018

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

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.

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Key information

Conditions

Pediatric Hematology Pediatric Oncology

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Performing a Hand Puppet to Music

Other

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.

Primary outcomes

  1. Procedure duration

    Time frame: During procedure

    Time from start to successful IV catheter placement.

  2. Number of IV catheter attempts:

    Time frame: During the IV procedure

    Recorded for each peripheral IV catheter placement.

Secondary outcomes

  1. Children's Fear Scale

    Time frame: 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.

  2. Children's Emotional Manifestation Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meltem Gürcan, PhD

CONTACT

[email protected]

+90 506 508 6214

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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