NCT07669948

Brief Summary

This single-center, parallel-group, randomized experimental study will compare the effects of two non-pharmacological distraction/coping interventions - cartoon watching and ball squeezing - on procedural pain and pain-related fear during venous blood sampling in children aged 6-9 years. The study will be conducted in the Pediatric Blood Collection Unit of Mersin University Hospital. Eligible children will be randomized to either the cartoon-watching group or the ball-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after venous blood sampling. Hypotheses

  • H1a: There is a difference between groups in mean WB-FACES scores during the procedure.
  • H1b: There is a difference between groups in mean CFS scores during the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

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

First Submitted

Initial submission to the registry

June 21, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

June 21, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

childpediatric nursingvenous blood samplingvenipuncturecartoon watchingstress ballnon-pharmacological intervention

Outcome Measures

Primary Outcomes (2)

  • Procedural pain score during venous blood sampling

    Procedural pain score during venous blood sampling, assessed using the Wong-Baker FACES Pain Rating Scale at puncture. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst/unbearable pain. Higher scores indicate greater pain. Time frame: during the procedure at puncture.

    during the procedure at puncture

  • Pain-related fear score during venous blood sampling

    Pain-related fear score during venous blood sampling, assessed using the Children's Fear Scale at puncture. The scale ranges from 0 to 4, from a neutral/no-fear face to a very fearful face. Higher scores indicate greater fear. Time frame: during the procedure at puncture.

    during the procedure at puncture

Secondary Outcomes (2)

  • Pre-procedure pain score

    two minutes before venous blood sampling

  • Pre-procedure pain-related fear score

    two minutes before venous blood sampling

Study Arms (2)

Cartoon-Watching Group

ACTIVE COMPARATOR

Watching a cartoon chosen by the child.

Behavioral: Cartoon-Watching Group

Ball-Squeezing Group

EXPERIMENTAL

Ball squeezing with a stress ball. A round, medium-firm, 2.25-inch-diameter stress ball that is safe for children, appropriate for child anatomy, resistant to tearing and damage, and suitable for cleaning and reuse will be used.

Behavioral: Ball-Squeezing Group

Interventions

Behavioral intervention: Cartoon watching. The child will begin watching a cartoon chosen by the child two minutes before venous blood sampling starts. Cartoon watching will continue until venous blood sampling is completed.

Cartoon-Watching Group

Behavioral intervention: Ball squeezing with a stress ball. The child will begin squeezing a stress ball chosen by the child two minutes before venous blood sampling starts. Ball squeezing will continue until venous blood sampling is completed.

Ball-Squeezing Group

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child aged 6-9 years
  • Child with need or plan for intravenous/venous blood sampling

You may not qualify if:

  • Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
  • Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Hospital

Mersin, Province, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guzide UGUCU, RN, MScN, PhD

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A and B. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm, single-center, parallel-group randomized experimental study comparing cartoon watching versus ball squeezing during venous blood sampling, with 1:1 allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

June 21, 2026

Primary Completion

July 21, 2026

Study Completion

July 21, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations