The Effect of Newborn Massage on Comfort Level and Vital Signs (NCT06529263) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Newborn Massage on Comfort Level and Vital Signs
Turkey (Türkiye)30 participantsStarted 2023-01-03
Plain-language summary
This study was planned as a randomized, controlled, experimental study to examine the effect of neonatal massage on the comfort level and vital signs of newborn babies.An answer to the question "Does massage applied to infants in the neonatal period have an effect on vital signs and comfort level?" will be sought.
Who can participate
Age range
1 Day – 7 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:
* Gestational age between 37-42 weeks,
* Birth weight of 2500 grams and above,
* The infant was hospitalized in the Neonatal Intensive Care Unit during data collection,
* Completion of 24 hours after birth
Exclusion Criteria:
* Gestational age below 37 weeks,
* Birth weight below 2500 grams,
* Refusal of the parent to participate in the study,
* The baby is on mechanical ventilation
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
Body temperature
Timeframe: Measurements were taken before and after the newborn massage 2 times a day for 4 days.
2
Pulse
Timeframe: Measurements were taken before and after the newborn massage 2 times a day for 4 days.
3
Respiration
Timeframe: Measurements were taken before and after the newborn massage 2 times a day for 4 days.
4
Understanding Pulse Oximetry
Timeframe: Measurements were taken before and after the newborn massage 2 times a day for 4 days.
5
Newborn comfort behaviors scale
Timeframe: Measurements were taken before and after the newborn massage 2 times a day for 4 days.