The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room (NCT07148570) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room
Turkey (Türkiye)60 participantsStarted 2025-08-26
Plain-language summary
Newborns may experience pain, stress, and physiological changes during and after birth. Appropriate nursing care during this period can reduce negative effects by increasing the baby's comfort. Kolbaba's Comfort Theory aims to provide holistic care by supporting physical, psychological, environmental, and sociocultural comfort. This study aims to investigate the effects of nursing interventions based on Kolcaba's theory on pain, comfort, crying duration, and physiological parameters (heart rate, respiratory rate, SpO₂, body temperature, etc.) in noenates delivered vaginally. The findings aim to reveal the contribution of comfort-focused approaches in noenates care to clinical outcomes.
Who can participate
Age range
0 Hours – 4 Hours
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:
* Vaginal delivery newborns in the delivery room
* Spontaneous vaginal delivery
* Stable condition (APGAR ≥7 at 5 minutes)
* No congenital anomalies
* Gestational age ≥37 weeks
* Birth weight ≥2500g
* No maternal sedation/analgesia in last 4 hours
* No neonatal resuscitation required
Exclusion Criteria:
* Preterm infants (\<37 weeks)
* Maternal fever (\>38°C) or chorioamnionitis
* Major congenital anomalies
* Need for NICU admission
* Maternal general anesthesia
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
COMFORTneo Scale
Timeframe: From the starting point to at least the second hour
2
Neonatal Pain Scale
Timeframe: From the starting point to at least the second hour