- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417852
Effect of Cartoon Projection and Ball Squeezing on Pain During Venipuncture in Children
Effect of Immersive Cartoon Projection and Ball Squeezing on Pain During Venipuncture Among Children: A Randomized Controlled Trial
The goal of this clinical trial is to learn which distraction method works better to reduce needle pain in children aged 4-12 years during blood draws.
The main questions it aims to answer are:
- Does watching cartoon videos lower children's pain more than squeezing a stress ball?
Which method do parents prefer for their children?
120 children will be randomly assigned to watch cartoons or squeeze a ball while nurses draw blood. Pain will be measured using a 0-10 pain scale right after the needle.
This study will help nurses choose the best way to make blood draws less painful for children.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study compares two distraction methods (cartoon projection vs. ball squeezing) to reduce venipuncture pain in children aged 4-12 years.
120 children will be randomized 1:1 to receive either immersive cartoon videos or tactile stress ball distraction during routine blood draws at Karbala Pediatric Hospital.
Pain intensity (primary outcome) will be assessed using Visual Analogue Scale (VAS, 0-10; higher=worse) immediately post-procedure.
The study protocol received ethical approval from University of Baghdad College of Nursing (No. 77, Jan 29, 2026).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Enas Ahmed, PhD Student
- Phone Number: 07806370150
- Email: ienas.ahmed1204a@conursing.uobaghdad.edu.iq
Study Locations
-
-
Karbala Governorate
-
Karbala, Karbala Governorate, Iraq, 0694
- Karbala Pediatric Teaching Hospital Al-Hussein Medical City Karbala, Iraq
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4-12 years
- Requiring venipuncture for routine blood testing
- Able to watch cartoon video during procedure
- Parental consent obtained
Exclusion Criteria:
- Developmental delay preventing cooperation
- Severe anxiety disorder
- Visual impairment
- Non-English/Arabic speaking parents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cartoon Projection Arm
Children receive immersive cartoon projection distraction during venipuncture
|
Immersive cartoon videos during venipuncture'
Stress ball squeezing during venipuncture'
|
|
Experimental: ball squeezing arm
Children aged 4-12 years receive ball squeezing distraction during venipuncture
|
Stress ball squeezing during venipuncture'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analogue Scale (VAS) Pain Score (0-10; higher scores = worse pain)
Time Frame: 0-30 seconds post - venipuncture
|
Child rates pain intensity (0-10 cm scale) immediately after needle insertion
|
0-30 seconds post - venipuncture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nurse-Observed Anxiety Level (1-5 scale; higher = worse)
Time Frame: During venipuncture procedure
|
Child anxiety assessed by nurse observer rating (1-5 scale)
|
During venipuncture procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enas Ahmed, PhD Student, University of Baghdad College of Nursing
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UOB-CON-77-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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