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
Qualifiers
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
Treatments tested in this trial
- Distraction-Card Group
- Emotion-Regulation Toy-Squeezing Group
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov