Effect of Using White Noise, Embracing and Facilitated Tucking in Newborns (NCT04837326) | Clinical Trial Compass
CompletedNot Applicable
Effect of Using White Noise, Embracing and Facilitated Tucking in Newborns
160 participantsStarted 2016-05-01
Plain-language summary
This study was conducted to evaluate the effect of using white noise, embracing and facilitated tucking on physiological parameters, crying duration and pain during heel lance blood sampling in healthy newborns.
This study was a prospective, randomized controlled trial. The study was conducted with healthy newborns who were born between 38 and 42 weeks of gestation. The newborns were divided into 4 groups by the applied pain relief methods during heel lance blood sampling in newborns; embracing(n=40), white noise(n=40), facilitated tucking(n=40) and control group (n=40). The physiological changes were evaluated before and after the procedure. NIPS (Neonatal Infant Pain Scale) was used for pain scoring.
Who can participate
Age range
1 Day – 28 Days
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:
* gestational age between 38 and 42 weeks,
* birth weight of 2500 - 4000 g,
* Apgar score of 8 and higher at 1st and 5th minute,
* having breastfed at least half an hour before the procedure,
* not showing any disease symptom,
Exclusion Criteria:
* having congenital anomaly,
* getting a good hearing test result
* having received any invasive intervention other than Vitamin K and Hepatitis B vaccine.
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.