Cartoon Watching Versus Ball Squeezing During Venous Blood Sampling in Children

June 25, 2026 updated by: Guzide UGUCU, Mersin University

The Effect of Cartoon Watching and Ball Squeezing on Pain and Pain-Related Fear During Venous Blood Sampling in Children Aged 6-9 Years: A Single-Center, Parallel-Group, Randomized Experimental Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is planned as a single-center, randomized experimental trial with two parallel intervention groups. The study population will consist of children aged 6-9 years for whom venous blood sampling is planned at Mersin University Hospital.

The sample size was calculated using a priori power analysis based on an effect size of d = 0.714 from Ugucu et al. (2022), with alpha = 0.05 and power = 0.80. The final sample is planned as 68 children, with 34 children in each intervention group.

Data Collection Instruments Child Information Form, developed after a literature review, will include variables such as the child's age, sex, previous hospitalization and venous blood sampling experience, and the presence and frequency of invasive procedure experience in the last week and in the last month.

The Wong-Baker FACES Pain Rating Scale is a valid and reliable measurement tool used to assess acute pain in children older than three years who can communicate. A score of 0 means no pain, and a score of 10 means unbearable/severe pain. According to scoring, 0-4 indicates mild pain, 5-6 moderate pain, 7-8 severe pain, and 9-10 unbearable pain. The approximate administration time is two minutes. Permission to use the scale was obtained by email.

The Children's Fear Scale assesses pain-related fear in children. The scale was developed by McMurtry et al. (2011), and its Turkish validity and reliability study was conducted by Ozalp-Gerceker et al. (2018). The scale consists of five drawn facial expressions scored from 0 to 4, ranging from a neutral expression (0 = no anxiety/fear) to a fearful face (4 = severe anxiety/fear). In the validity and reliability study, the Content Validity Index was 0.89. Because the Children's Fear Scale is scored from 0 to 4, construct validity could not be performed. Test-retest reliability was very high (0.99). The cut-off point is 2; scores of 2 and above are considered high fear. The Children's Fear Scale is a valid and reliable measurement tool. Its approximate administration time is two minutes. Permission to use the scale was obtained from the author by email.

The Pediatric Blood Collection Unit is decorated with cartoon characters and ornaments. Only one child can undergo the procedure in the room at a time. Routine practice supports parental presence during all invasive procedures. Nurses routinely wear uniforms with cartoon-character prints/patterns. Environmental conditions such as lighting, temperature, noise, and seating are the same for all children and parents. The nurse who performs venous blood sampling will be the same for all groups and children and has five years of pediatric service experience.

Randomization and Allocation Concealment Block randomization will be used to preserve balance in participant numbers between groups. The randomization list will be generated by an independent statistician using simple random selection through randomizer.org. After block randomization, sequential numbers will be placed in closed opaque envelopes to conceal allocation.

Before the procedure, children will receive an explanation appropriate to their developmental level, and physical comfort will be ensured in the blood collection room. In the cartoon-watching group, the child will start watching a cartoon selected by the child two minutes before venous blood sampling begins. In the ball-squeezing group, the child will start squeezing a stress ball selected by the child two minutes before venous blood sampling begins. For both groups, the intervention will be terminated when venous blood sampling is completed. After the procedure, children will be given a star-shaped sticker as a gift.

Pain and pain-related fear scores will be recorded by the researchers two minutes before the procedure, during the procedure at the time of puncture, and one minute after the procedure. Data during and after the routine planned venous blood sampling procedure will be recorded by the researchers.

Statistical Analysis Plan Data will be analyzed using a statistical package program. The level of statistical significance will be set at 0.05. The Kolmogorov-Smirnov test will be used to assess normality of dependent variables. Chi-square tests and tests comparing means will be used to determine group similarity. Appropriate parametric or non-parametric tests will be used to compare between-group and within-group means depending on whether the distribution is normal. If differences are found between group means, an effect size appropriate to the test family will be used.

Ethics, Consent, and Assent The study will begin after obtaining ethics committee approval from the Mersin University Health Sciences Research Ethics Committee, written institutional permission, written informed consent from parents/legal representatives, and verbal assent from children.

Study Type

Interventional

Enrollment (Estimated)

68

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 Locations

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

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cartoon-Watching Group
Watching a cartoon chosen by the child.
Behavioral: Cartoon-Watching Group
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.
Experimental: Ball-Squeezing Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural pain score during venous blood sampling
Time Frame: during the procedure at puncture
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
Time Frame: during the procedure at puncture
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-procedure pain score
Time Frame: two minutes before venous blood sampling
Pre-procedure pain score assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst/unbearable pain. Higher scores indicate greater pain.
two minutes before venous blood sampling
Pre-procedure pain-related fear score
Time Frame: two minutes before venous blood sampling
Pre-procedure pain-related fear score assessed using the Children's Fear Scale. The scale ranges from 0 to 4, from a neutral/no-fear face to a very fearful face. Higher scores indicate greater fear.
two minutes before venous blood sampling

Collaborators and Investigators

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

Sponsor

Mersin University

Investigators

  • Principal Investigator: Guzide UGUCU, RN, MScN, PhD, Mersin University

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 (Actual)

June 21, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 7, 2026

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MersinU*GUGUCU_007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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.

Clinical Trials on Procedural Pain

Clinical Trials on Cartoon-Watching Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe