NCT07041216

Brief Summary

This randomized controlled trial investigates the effects of two non-pharmacological techniques-squishy toy squeezing and vein palpation-on the success rate of peripheral intravenous catheter (PIVC) insertion in pediatric hematology and oncology patients. Data collection takes place in the procedure room of a pediatric outpatient clinic. The study includes children who have a Difficult Intravenous Access (DIVA) score of 4 or higher, indicating difficult venous access. Participants are randomly assigned to one of three groups: the squishy toy group, the palpation group, or the control group, which receives standard care. In the squishy toy group, children use soft, elastic toys to activate hand muscles and improve blood flow, aiming to enhance vein visibility. In the palpation group, the target vein is gently tapped to increase local blood circulation and make the vein more prominent. The control group undergoes catheter insertion without any additional stimulation techniques. All data are recorded using structured forms that collect demographic, clinical, and procedural information. The study aims to determine whether these simple and cost-effective interventions improve the success rate of PIVC insertion in children with difficult venous access.

Trial Health

87
On Track

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
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

June 12, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

Squishy Toy SqueezingPeripheral Intravenous Catheter Insertion SuccessPalpation TechniquesPediatric Hematology and Oncology

Outcome Measures

Primary Outcomes (2)

  • Number of IV attempts to successful acces

    During the procedure, the number of intravenous catheter insertion attempts is measured using the catheter documentation form.

    During the procedure

  • Time to successful acces

    During the procedure, the total procedure time is measured using the catheter documentation form.

    During the procedure

Study Arms (3)

Squishy Toy Group

EXPERIMENTAL

In the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward, the child stopped using the toy. Once the vein was visible, the catheter was inserted and the tourniquet removed.

Other: Squishy Toy Squeezing

Palpation Group

EXPERIMENTAL

In this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the palpation procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions.

Other: Palpation

Control Group

OTHER

This group received standard IV insertion with no extra techniques applied.

Other: Routine medical care

Interventions

In the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward,

Squishy Toy Group

In this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the tapping procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions.

Palpation Group

This group received standard IV insertion with no extra techniques applied.

Control Group

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children identified by the healthcare team as needing peripheral intravenous catheter placement who also have a Difficult Intravenous Access (DIVA) score of 4 or above.

You may not qualify if:

  • Children unable to squeeze a toy due to physical limitations were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Antalya, (506) 508 62 14, Turkey (Türkiye)

Location

Related Publications (1)

  • Gurcan M, Say B, Yayla N, Atay Turan S. Effectiveness of toy-mediated hand squeezing or palpation in peripheral IV catheterization among pediatric hematology and oncology patients: A randomized controlled trial. Eur J Oncol Nurs. 2025 Dec;79:103005. doi: 10.1016/j.ejon.2025.103005. Epub 2025 Oct 13.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 27, 2025

Study Start

December 1, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations