NCT07493018

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2026Oct 2026

First Submitted

Initial submission to the registry

March 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 20, 2026

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Procedure duration

    Time from start to successful IV catheter placement.

    During procedure

  • Number of IV catheter attempts:

    Recorded for each peripheral IV catheter placement.

    During the IV procedure

Secondary Outcomes (2)

  • Children's Fear Scale

    Measured before and immediately after IV catheter placement

  • Children's Emotional Manifestation Scale

    During procedure

Study Arms (3)

Hand Puppet

EXPERIMENTAL

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

Squeeze Toy

EXPERIMENTAL

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)

Control

NO INTERVENTION

Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques.

Interventions

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 Puppet

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.

Squeeze Toy

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Physical condition preventing use of a squeeze toy.
  • Cognitive or developmental disorders preventing understanding of procedural instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.

    PMID: 39002409BACKGROUND
  • Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17.

    PMID: 39293201BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Assistant

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 25, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share