Stress Level, Skin Moisture and Physiological Parameters in the First Bath of Newborns (NCT07109908) | Clinical Trial Compass
CompletedNot Applicable
Stress Level, Skin Moisture and Physiological Parameters in the First Bath of Newborns
Turkey (Türkiye)72 participantsStarted 2024-01-01
Plain-language summary
Objectıve: The aim of this study was to determine the effect of wipe (WG), shower (SG) and tub bath (TG) on stress level, skin moisture and physiological parameters used during the first bath in newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
Hypotheses of the Research
Hypothesis 01,2,3: There is no difference between wiping baths, wrapping baths and shower baths in terms of their effects on thermoregulation, stress level, skin moisture and physiological parameters of newborns.
Hypothesis 11: Newborns who are given a wrap-up bath have a lower stress level than if they are swept and showered.
Hypothesis 12: Newborns who are given a wrap-up bath have better skin moisture levels than newborns who are wiped and showered.
Hypothesis 13: Physiological parameters (body temperature, heart peak, respiratory rate, oxygen saturation) of newborns who are given a wrap bath are less affected than wiping and showering.
Who can participate
Age range
1 Month – 2 Months
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:
* Birth weight of 2500 g or more
* Body temperature within the normal range (36-37.3°C)
* Respiratory rate between 30-60 breaths per minute
* Oxygen saturation above 85%
* Absence of neurological problems (e.g., hypotonia, hypertonia)
* Absence of congenital defects
* No dermatological problems
* Parental consent and voluntary participation in the research
Exclusion Criteria:
* Presence of respiratory failure or distress
* Requirement for ventilator support
* Continuous need for high-concentration oxygen via methods such as hood or CPAP
* History of convulsions
* Clinical evidence of infection
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
1
Physiological Variables Follow-up Form
Timeframe: Just before bathing, just after bathing, and 30 minutes after bathing
2
Skin Moisture Tracking Form
Timeframe: 6th hour, 12th hour and 24th hour just before and after bath
3
Neonatal Stress Scale
Timeframe: 10 min before bathing, during bathing, just after bathing, 15 and 30 min after bathing