CompletedNot Applicable

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children

Turkey (Türkiye)120 participantsStarted 2023-10-25

Plain-language summary

The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.

Who can participate

Age range

4 Years – 6 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: * The child and family agree to participate in the research, * The child is between the ages of 4-6, * The child does not have a chronic and mental health problem, * Absence of visual, auditory problems or mental retardation at a level that can fill the scales, * No history of sedative, analgesic or narcotic substance use within 24 hours before admission, * Absence of a disease causing chronic pain, * Not having a febrile illness at the time of application, * Being treated in the pediatric emergency unıt at the time of the study, * Intramuscular injection in the vastus lateralis region, * Ondansetron will be injected intramuscularly in the vastus lateralis area, as directed by the doctor. * Performing the operation at once. Exclusion Criteria: * The child and family's refusal to participate in the research, * Having a visual and auditory problem * The child is less than 4 years old or older than 6 years old * The child has a chronic and mental health problem * The child experiences pain, * To have taken analgesic medication in the last 6 hours.

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

Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES

Timeframe: Pain levels of the children will be evaluated 1 minute after the procedure.

Comparison of the fear score values of the groups

Timeframe: Children's fear levels will be evaluated first 1 minutes before the procedure.

Comparison of the fear score values of the groups

Timeframe: Children's fear levels will be evaluated 1 minutes after the procedure.

Trial details

NCT IDNCT06354608

SponsorUniversity of Yalova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-21

View on ClinicalTrials.gov More Procedural Pain trials

Who can participate

Age range

4 Years – 6 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

Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES

Timeframe: Pain levels of the children will be evaluated 1 minute after the procedure.

Comparison of the fear score values of the groups

Timeframe: Children's fear levels will be evaluated first 1 minutes before the procedure.

Comparison of the fear score values of the groups

Timeframe: Children's fear levels will be evaluated 1 minutes after the procedure.