CompletedNot Applicable

The Effect of Gentle Human Touch in Preterm Infants During Heel Lancing

Turkey (Türkiye)50 participantsStarted 2021-08-10

Plain-language summary

This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The study will be performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. The therapeutic touch will be applied 10 minutes before the heel lancing, it will continue during and after the procedure, a total of 15 minutes of sensitive touch will be applied. The practitioner will place one hand on the baby's head and the other hand on the lower abdomen covering the waist and hips of the preterm baby for 15 minutes. Before and after the study the following were evaluated in preterm infants in the gentle human touch and control group: pain, comfort and physiological parameters.

Who can participate

Age range

32 Weeks – 37 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: * Being 32-37 gestational age weeks, * being birth weight of 1500 g and above, * without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis, * no chest tube, * not connected to a mechanical ventilator, * not having intracranial bleeding, * not taking any medication other than antibiotics and vitamin supplements, * not taking opiates and sedatives within 4 hours before heel lancing, * no painful intervention is applied at least one hour before the heel lancing, * preterm infants whose mothers gave verbal and written consent Exclusion Criteria: * having a congenital anomaly, having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis, * being chest tube, * connected to a mechanical ventilator, * having intracranial bleeding, * taking any medication other than antibiotics and vitamin supplements, * taking opiates and sedatives within 4 hours before heel lancing, * painful intervention is applied at least one hour before the heel lancing

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

Premature infants comfort scale (PICS) scores

Timeframe: before the heel lancing, during the heel lancing and after heel lancing 15. minute

Trial details

NCT IDNCT05001191

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-10

View on ClinicalTrials.gov More Heel Lancing trials