Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children

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

The Effect of Using Distraction Card and Squeezing Emotion-Regulation Toy on Pain and Pain-Related Fear During Intramuscular Vaccination in Children Aged 4-7 Years: A Single-Center, Parallel-Group, Randomized Experimental Study

This single-center, parallel-group, randomized experimental study will compare the effects of two active non-pharmacological interventions - distraction-card use and emotion-regulation toy squeezing - on procedural pain and pain-related fear during intramuscular tetanus vaccination in children aged 4-7 years. Eligible children will be randomized to either the distraction-card group or the emotion-regulation toy-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 the intramuscular injection procedure.

Hypotheses

  • H1a: There is a difference between the groups in mean Wong-Baker FACES scores during the procedure.
  • H1b: There is a difference between the groups in mean Children's Fear Scale 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 active intervention groups. The study population will consist of children aged 4-7 years for whom intramuscular tetanus vaccination 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.

The Pediatric Vaccination/Injection Unit will be arranged to provide the same environmental conditions for all children and parents, including lighting, temperature, noise level, seating, and procedural workflow. It is decorated with cartoon characters and ornaments. Only one child will undergo the procedure in the room at a time. Routine practice will support parental presence during the invasive procedure. The nurse who performs the intramuscular tetanus vaccination will be the same for both groups and children where feasible and will have pediatric clinical experience.

Before the procedure, children will receive an explanation appropriate to their developmental level, and their physical comfort will be ensured. In the distraction-card group, the child will begin using age-appropriate distraction cards two minutes before the intramuscular injection. The child will be actively engaged with the cards through visual attention and simple developmentally appropriate prompts until the injection procedure is completed. In the emotion-regulation toy-squeezing group, the child will begin squeezing an age-appropriate emotion-regulation toy two minutes before the intramuscular injection and will continue until the procedure is completed.

Pain and pain-related fear scores will be recorded by the researchers two minutes before the procedure, during the procedure at needle insertion/vaccine administration, and one minute after the procedure. Data will be collected during the routinely planned intramuscular tetanus vaccination procedure without delaying or replacing standard clinical care.

Data Collection Instruments The Child Information Form, developed after a literature review, will include variables such as the child's age, sex, previous hospitalization and injection/vaccination experience, previous invasive procedure 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 should be documented before data collection if required.

The Children's Fear Scale assesses pain-related fear in children. 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). Scores of 2 and above are commonly interpreted as high fear in the source methodology. The approximate administration time is two minutes. Permission to use the scale should be documented before data collection if required.

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 the 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.

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 or equivalent computer-assisted randomization. After block randomization, sequential numbers will be placed in closed opaque envelopes to conceal allocation.

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 from the relevant hospital/unit, written informed consent from parents/legal representatives, and verbal assent from children when developmentally appropriate.

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

No

Description

Inclusion Criteria:

  • Child aged 4-7 years
  • Child with need or plan for intramuscular vaccination

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: Distraction-Card Group
Arm type: Experimental. Behavioral intervention: active distraction-card use. Two minutes before the intramuscular tetanus vaccination begins, the child will start using age-appropriate distraction cards. The child will be actively engaged with the cards through visual attention and simple prompts until the injection procedure is completed.
Behavioral: Distraction-Card Group
Age-appropriate visual distraction cards suitable for children aged 3-6 years will be used. Cards should be cleanable or single-use according to infection-control practice and should include developmentally appropriate visual content that can maintain the child's attention during the procedure. Two minutes before the intramuscular tetanus vaccination begins, the child will start using age-appropriate distraction cards. The child will be actively engaged with the cards through visual attention and simple prompts until the injection procedure is completed.
Experimental: Emotion-Regulation Toy-Squeezing Group
Arm type: Experimental. Behavioral intervention: active emotion-regulation toy squeezing. Two minutes before the intramuscular tetanus vaccination begins, the child will start squeezing an age-appropriate emotion-regulation toy. The toy-squeezing intervention will continue until the injection procedure is completed.
Behavioral: Emotion-Regulation Toy-Squeezing Group
A safe, age-appropriate, cleanable, medium-firm squeezable emotion-regulation toy appropriate for children aged 3-6 years will be used. The toy should be resistant to tearing and damage and suitable for infection-control procedures between participants if reusable. Two minutes before the intramuscular tetanus vaccination begins, the child will start squeezing an age-appropriate emotion-regulation toy. The toy-squeezing intervention will continue until the injection procedure is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural pain score during intramuscular vaccination
Time Frame: during the procedure at needle insertion/vaccine administration
Procedural pain score during intramuscular tetanus vaccination, 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.
during the procedure at needle insertion/vaccine administration
Pain-related fear score during intramuscular vaccination
Time Frame: during the procedure at needle insertion/vaccine administration
Pain-related fear score during intramuscular tetanus vaccination, 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.
during the procedure at needle insertion/vaccine administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-procedure pain score
Time Frame: two minutes before intramuscular vaccination
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 intramuscular vaccination
Pre-procedure pain-related fear score
Time Frame: two minutes before intramuscular vaccination
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 intramuscular vaccination

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)

September 15, 2026

Study Completion (Estimated)

November 20, 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_008

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.

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