EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE (NCT07673133) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE
72 participantsStarted 2027-02
Plain-language summary
The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters.
Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.
Who can participate
Age range
0 Days – 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:
* Newborns with a gestational age between 32 0/7 and 36 6/7 weeks
* Newborns with an APGAR score above 6 at 5 minutes
* Newborns weighing over 1000 grams
* Newborns not on mechanical ventilation
* Newborns who have been fed at least one hour prior to care
* Newborns cared for in an incubator
* Newborns who have passed the hearing test
Exclusion Criteria:
* Presence of a condition that prevents the assessment of stress and physiological parameters (birth trauma, intracranial hemorrhage, congenital anomaly, etc.),
* Undergoing an invasive procedure that causes different stress at least one hour before the care (intravenous access, aspiration procedure, etc.),
* Administration of sedatives, opioids, and anticonvulsant drugs before the 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
1
Neonatal Stress Assessment Scale
Timeframe: The Neonatal Stress Scale will be completed by a pre-assigned nurse approximately 1 minute before care begins, 5 minutes after care starts, and 1 minute after care ends. The same nurse will then complete the stress scale and the newborn follow-up form.