CompletedNot Applicable

Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children

Turkey (Türkiye)180 participantsStarted 2025-01-10

Plain-language summary

This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure. Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure. Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 7 to 12 years * Able to read and write * No chronic disease * No visual, hearing, verbal communication, cognitive, or neurological impairment * No use of sedative, analgesic, or narcotic medication within 24 hours before the procedure * Willingness of both the child and parent to participate in the study Exclusion Criteria: * Child's refusal to participate or continue the assessment process * Parent's request to withdraw from the study * Inability to complete the blood draw procedure in a single attempt * Missing essential data required for analysis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wong-Baker FACES Pain Rating Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure

Children's Fear Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure

Children's Anxiety Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure

Trial details

NCT IDNCT07689370

SponsorKocaeli University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-24

View on ClinicalTrials.gov More Procedural Pain trials

Plain-language summary

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wong-Baker FACES Pain Rating Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure

Children's Fear Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure

Children's Anxiety Scale Score

Timeframe: Immediately before and immediately after the blood draw procedure