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

March 25, 2026 updated by: Meltem Gürcan, Akdeniz University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand 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.
Other: Performing 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.
Experimental: 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. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration.
Other: Hand 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.
No Intervention: Control
Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure duration
Time Frame: During procedure
Time from start to successful IV catheter placement.
During procedure
Number of IV catheter attempts:
Time Frame: During the IV procedure
Recorded for each peripheral IV catheter placement.
During the IV procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured before and immediately after IV catheter placement
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.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AkdenizUnOncology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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