CompletedNot Applicable

The Effect of Parental Participation on Newborn Comfort During Diaper Care

Turkey (Türkiye)105 participantsStarted 2023-12-19

Plain-language summary

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants. H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort. H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants. H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

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: * Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application * Infants with stable health conditions Exclusion Criteria: * Intubated * Those with very low and extremely low birth weight at the time of procedure * Having a chronic disease * Those with congenital anomalies * Having undergone a surgical procedure * Having neurological symptoms * Receiving oxygen support * Diagnosed with sepsis * Sedated * A pharmacological analgesic method was used four hours before. * Parents who do not want to participate in care

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

Level of Parental Stress

Timeframe: It will be measured once just before the diaper care

Change in Level of Comfort

Timeframe: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed

Trial details

NCT IDNCT06345742

SponsorAcibadem University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-18

View on ClinicalTrials.gov More Preterm trials