Using audio books and vibration to reduce pain and fear during children's injections
The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study
This study tests if listening to an audiobook and feeling vibrations can help reduce pain and fear in young children during their injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | University of Yalova Academic / other |
| Locations | 1 site (Yalova) |
| Trial ID | NCT06354608 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of an audio book and local vibration on pain and fear experienced by children aged 4-6 during intramuscular injections in a pediatric emergency unit. It employs a randomized controlled experimental design to assess how these non-pharmacological interventions can alleviate distress associated with painful medical procedures. The goal is to improve pain management and emotional responses in young patients, potentially leading to better healthcare experiences in the future.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-6 who are receiving intramuscular injections in a pediatric emergency setting and do not have chronic or mental health issues.
Not a fit: Patients who may not benefit from this study include those with chronic pain conditions, mental health problems, or those outside the specified age range.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and fear in children undergoing medical procedures, improving their overall healthcare experience.
How similar studies have performed: Other studies have shown success with similar non-pharmacological approaches to pain management in pediatric settings, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Yalova
- University of Yalova — Yalova, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Derya Kılıç, Assis. Prof. — Researcher
- Study coordinator: Duygu Demir, Assis. Prof.
- Email: duygu.demir@yalova.edu.tr
- Phone: +905053662358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.