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

NCT07669961 | Recruiting

• 1 other identifier: MersinU*GUGUCU_008
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Pain; Pain-related Fear

Keywords

child; pediatric nursing; intramuscular vaccination; distraction methods; active distraction

Outcome Measures

Primary Outcomes (2)

• Procedural pain score during intramuscular vaccination

  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

  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 Outcomes (2)

• Pre-procedure pain score

  two minutes before intramuscular vaccination

• Pre-procedure pain-related fear score

  two minutes before intramuscular vaccination

Study Arms (2)

Distraction-Card Group

ACTIVE COMPARATOR

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

Emotion-Regulation Toy-Squeezing Group

EXPERIMENTAL

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

Interventions

Distraction-Card Group BEHAVIORAL

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.

Distraction-Card Group

Emotion-Regulation Toy-Squeezing Group BEHAVIORAL

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.

Emotion-Regulation Toy-Squeezing Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Hospital

Mersin, Province, 33343, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological 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
• 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 (Estimated): September 15, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)