An interventional study of Kangaroo Care and Routine Care in Procedural Pain and Neonatal Hyperbilirubinemia, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Marmara University · Not applicable, Interventional, and Health services research
This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.
Kangaroo care is a highly effective, low-cost, and feasible method for reducing crying duration and alleviating pain in newborns. This method is most commonly provided by the mother. However, the World Health Organization states that when the mother is unable to participate, kangaroo care may also be provided by other family members, such as the father or grandmother, a close friend, or a trained healthcare professional. Particularly in neonatal intensive care unit settings, it is not always possible for mothers to remain continuously with their infants outside visiting hours. During periods when the mother is unavailable, nurses may be considered as alternative providers of kangaroo care for pain management; however, due to the limited scientific evidence on this topic, the effectiveness of nurse-provided kangaroo care remains unclear. By addressing this gap in the literature, the present study aims to examine the effect of nurse-provided kangaroo care on neonatal pain levels and to contribute to the field of neonatology as an atraumatic care practice.
Newborns participating in the study will be randomly assigned using a simple randomization method to three groups: experimental group 1 (mother-provided kangaroo care), experimental group 2 (nurse-provided kangaroo care), and the control group. Newborns in experimental group 1 will receive kangaroo care by being placed, wearing only a diaper, in direct skin-to-skin contact with their mother's bare chest. The intervention will be initiated 15 minutes before the heel-prick blood sampling procedure, maintained throughout the procedure, and continued for an additional 15 minutes after the procedure. To eliminate the potential effects of hunger or satiety on neonatal pain responses, all newborns will be fed at least 30 minutes prior to the procedure.
Physiological parameters, including oxygen saturation (SpO₂), heart rate, respiratory rate, and body temperature, will be measured and recorded using a monitor before the procedure (0 minute), during the procedure, and at 2 and 10 minutes after the procedure. Phototherapy will not be interrupted during the procedure. Heel-prick blood sampling will be performed by a neonatal intensive care unit nurse after cleansing the puncture site with 70% alcohol and allowing it to dry, using an automatic lancet routinely employed in the unit.
Pain levels and crying duration will be assessed using video recordings obtained before, during, and after the procedure (at 2 and 10 minutes). These recordings will be evaluated after completion of the procedure by both the researcher and an independent observer (a neonatal intensive care unit nurse) using the Neonatal Infant Pain Scale (NIPS), and the results will be recorded on the observation form. Newborns in experimental group 2 will receive nurse-provided kangaroo care, and all intervention, measurement, and evaluation procedures will be conducted in the same manner as in experimental group 1. Newborns in the control group will undergo heel-prick blood sampling in a standard position within an incubator, in accordance with routine hospital practices, without the application of kangaroo care; all measurement and evaluation procedures will be conducted in the same manner as in experimental groups 1 and 2.
If the results of the study demonstrate that mother-provided kangaroo care is more effective, recommendations may be developed to strengthen family-centered care practices. Alternatively, if nurse-provided kangaroo care is shown to produce comparable effects, nurses may be encouraged to incorporate this method into neonatal care protocols as a standard practice in situations where the mother is unavailable, deceased, or unable to provide kangaroo care. Through this study, non-pharmacological pain management strategies may be updated, thereby contributing scientifically to neonatal care through nurses' implementation of atraumatic care practices. In addition, the findings of this study may provide a foundation for future research.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 45 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the mother's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher after reviewing the video recordings.
Behavioral: Kangaroo Care
Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the researcher's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.
Behavioral: Kangaroo Care
Infants in this group will undergo the heel-stick procedure in a standard position inside the incubator in accordance with hospital routine, and kangaroo care will not be applied. Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.
Behavioral: Routine Care
In this study, kangaroo care is applied as the intervention. Kangaroo care is defined as placing the newborn, wearing only a diaper, in a prone and upright position on the bare chest of the mother (or caregiver), with the infant's back covered with a blanket to prevent heat loss. The intervention is applied during the heel-prick blood sampling procedure in newborns receiving phototherapy, beginning a specified period before the procedure and continuing throughout the procedure. The duration of kangaroo care and the application conditions are standardized for all participants, and no additional analgesic or pharmacological interventions are administered during the intervention.
Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.
Hearth rate
hearth rate of the infant in 1 minutes
Time frame: 30 minutes
respiratory rate
respiratory rate of the infant in 1 minutes
Time frame: 30 minutes
O2 saturation
O2 saturation of the infant
Time frame: 30 minutes
body temperature
body temperature of the infant
Time frame: 30 minutes
duration of crying
duration of crying of the infant
Time frame: 30 minutes
Neonatal Infant Pain Scale
The total score on the NIPS pain scale ranges from 0 to 7. Scores higher than 3 indicate the presence of pain.
Time frame: 30 minutes
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 6 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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