The Effect of Paternal Skin-to-Skin Contact on Neonatal Parameters (NCT06956859) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Paternal Skin-to-Skin Contact on Neonatal Parameters
Turkey (Türkiye)80 participantsStarted 2022-05-15
Plain-language summary
This study was planned to examine the effect of skin-to-skin contact between the babies of mothers who gave birth by cesarean section and their fathers on the physiological parameters and comfort of the newborn. The research, which is in a randomized controlled experimental design, will be carried out at the Ministry of Health Sakarya University Training and Research Hospital.
The spouses and babies of 80 pregnant women who were hospitalized with a planned cesarean delivery in Sakarya Training and Research Hospital Gynecology and Child Additional Service Building, will be divided into intervention and control groups by simple randomization method.
Paternal skin-to-skin contact will be applied to newborns in the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort Behavior Scale will be applied to the cases included in the study, body temperature, oxygen saturation, heart rate, respiration will be evaluated, and salivary cortisol analysis will be performed.
The discussion and results of the study will be written in the accompaniment of the findings.
Who can participate
Age range
5 Minutes – 15 Minutes
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:
Inclusion criteria for newborns;
* Being born at term (38-42 weeks of gestation)
* Birth weight between 2500-4000gr
* 1st and 5th minute apgar score of 7 and above
* The newborn does not have any health problems
* No surgical intervention
Inclusion criteria for fathers
* No communication problems,
* At least primary school graduate,
* over 18 years old,
Exclusion Criteria:
Neonatal exclusion criteria
* Congenital anomalies
* Metabolic diseases
* Severe periventricular/intraventricular bleeding
* History of minor or major surgery
* Babies from single-parent families
* Babies with intubation and mechanical ventilation
* Having a birth weight of less than 2500 g and more than 4000 g.
Exclusion criteria for fathers
* Unwillingness to participate in the study
* Any contagious disease that can be transmitted through skin contact
* Experiencing fatherhood for the first time
* Not having any contagious disease that can be transmitted through skin contact
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.