The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns (NCT05079594) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns
Turkey (Türkiye)60 participantsStarted 2021-03-15
Plain-language summary
The heel blood procedure for newborn screening is done for almost all babies within the first 48 hours of birth. It is stated that non-pharmacological methods in reducing pain during the heel blood collection process are simple, effective, free, and very cost-effective. Studies have shown that auditory interventions (such as mother's voice, white noise) used in invasive procedures distract the infant and create a cognitive strategy for pain control. According to this information, one aim of the study is to determine the effect of the mother's voice and white noise, which are non-pharmacological methods, on the comfort level of the baby in the heel blood procedure. It is thought that especially acute painful procedures applied to infants will reduce the level of stress and anxiety in parents. Another aim of this study is to determine the effect of a mother's voice and white noise, which are non-pharmacological methods, on the state anxiety levels of mothers in the heel blood collection process.
Who can participate
Age range
1 Hour – 1 Month
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
. Newborns whose postnatal age is between 1-5 days,
. 38-42. newborns born between gestational weeks,
. Healthy newborns,
. Babies of mothers without diabetes,
. Newborns who were not given any opioid and non-opioid drugs before the application,
. Newborns who have been fed at least 30 minutes ago,
. Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included.
. Mothers who can speak and understand Turkish,
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.
. If the lancet cannot be inserted and removed at once, the baby will be excluded from the study.
. Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby.