Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorMersin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Child aged 4-7 years
Child with need or plan for intramuscular vaccination
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Distraction-Card Group
BehavioralAge-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.
Emotion-Regulation Toy-Squeezing Group
BehavioralA 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Distraction-Card GroupActive comparator 1 intervention
Group B: Emotion-Regulation Toy-Squeezing GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
during the procedure at needle insertion/vaccine administration2
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.
Time frame
during the procedure at needle insertion/vaccine administrationSecondary outcomes
1
Pre-procedure pain score
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.
Time frame
two minutes before intramuscular vaccination2
Pre-procedure pain-related fear score
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.
Time frame
two minutes before intramuscular vaccinationSponsors and contacts
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Source ClinicalTrials.gov