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Completed NCT07816965

The Effects of Two Methods Applied on Pain and Fear During Phlebotomy in Children

Conditions: Distraction Methods, Pain Management, Fear, Narration, Pediatric, Phlebotomy

Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 138
Sponsor: Sinem Basdemir

Location: Izmir Bakircay University Cigli Training and Research Hospital Izmir

Summary

Objective: This study aimed to evaluate the effects of using an externally vibrating dolphin-shaped Dolphin massage device and digital storytelling via tablet on pain and fear in children aged 3 to 6 years during blood collection. Method: This randomized controlled trial was conducted with 105 children aged 3-6 years who visited the pediatric blood collection unit of a training and research hospital between June 2024 and June 2025. This study used the CONSORT checklist. After obtaining consent from the child and parent, the children (n=105) were assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)) using block randomization. The children's pain and fear scores were assessed after phlebotomy by their parents, the nurse performing the phlebotomy, and the researcher using the Wong-Baker Pain Scale and the Child Fear Scale. The phlebotomy procedure was performed by a single nurse.

Eligibility Criteria

Inclusion Criteria: * Children whose parents and themselves agree to participate in the study * Children from whom blood was successfully drawn on the first attempt Exclusion Criteria: * Children with chronic illnesses, * Children with intellectual disabilities, * Children who have received analgesics in the last 24 hours, * Children who have undergone surgery, * Children who are hospitalized, * Children from whom blood could not be drawn on the first attempt * Children who do not agree to participate in the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07816965). StuddyBuddy aggregates publicly available trial information.