Maternal Sensory Interventions in Newborns (NCT07725094) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Maternal Sensory Interventions in Newborns
Turkey (Türkiye)80 participantsStarted 2026-08-15
Plain-language summary
This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.
Who can participate
Age range
35 Weeks – 42 Weeks
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 35 and 42 completed weeks.
* Birth weight between 2,000 and 4,200 grams.
* Clinically stable newborn admitted to the neonatal intensive care unit.
* Spontaneous breathing without the need for mechanical ventilation.
* Not receiving sedative medications.
* Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
* Five-minute Apgar score \<4.
* Requirement for advanced resuscitation after birth.
* Presence of a major congenital anomaly.
* Requirement for invasive intervention involving the head region.
* Diagnosed central nervous system dysfunction or neurological disorder.
* Presence of severe postnatal medical complications that may affect study outcomes.
Exclusion Criteria (during the research):
* The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.
* A parent or legal guardian withdraws consent for the newborn's participation in the study.
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
Sleep-Wake States Assessed by Bispectral Index
Timeframe: During the 60-minute observation period following routine midday care and feeding
2
Sleep Onset Latency
Timeframe: From the beginning of the intervention until sleep onset, assessed within 60 minutes
3
Mean Bispectral Index Score
Timeframe: During the 60-minute observation period