CompletedNot Applicable

The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns

Turkey (Türkiye)72 participantsStarted 2022-02-15

Plain-language summary

The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.

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: * The week of gestation is between 37 and 41 weeks, * Birth weight being 2500 g and above, * Having spontaneous breathing, * Its physiological parameters are stable, * Having completed the first 24 hours of life, * No invasive interventions should be made before the bathing process. Exclusion Criteria: Preterms with a gestational age of 22-37 weeks, * Connected to mechanical ventilator, * Those who have been wiped or bathed in the last 12 hours, * Within the first 78 hours of the post-operative period, * With central catheter, * Diagnosed with sepsis, * Those who use sedative and/or muscle relaxants, * Those with congenital, chromosomal anomalies,

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

change in stress

Timeframe: 15th minute after the procedure

change in comfort

Timeframe: 15th minute after the procedure

Trial details

NCT IDNCT06171997

SponsorFunda Kardas Ozdemir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

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