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NCT Number: NCT07761689

The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy

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.

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Key information

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ebru UYGUR, MSc

PRINCIPAL_INVESTIGATOR

Ebru UYGUR, MSc(student)

CONTACT

[email protected]

05336822564

Çağrı ÇÖVENER ÖZÇELİK, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation of the mother
  • Gestational age of 38 weeks or more
  • Diagnosis of physiological hyperbilirubinemia only
  • Serum bilirubin level within the moderate-high range (13-18 mg/dL) according to the Turkish Neonatal Society Guideline for the Management, Follow-up, and Treatment of Neonatal Jaundice (2022 update)
  • Postnatal age between 2 and 7 days
  • Absence of any condition preventing the infant from feeding
  • Absence of any maternal health condition that would preclude the application of kangaroo care
  • Ability of the mother to speak Turkish and to understand the information provided about the study

Exclusion criteria

  • Gestational age less than 34 weeks or 38 weeks and above
  • Diagnosis of sepsis or any other systemic infection
  • Presence of congenital anomalies
  • Diagnosis of pathological jaundice
  • Use of antibiotic therapy
  • Serum bilirubin level greater than 18 mg/dL
  • Postnatal age greater than 7 days
  • Mother's refusal to participate in the study

Treatment and study plan

Kangaroo Care

Behavioral

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.

Routine Care

Behavioral

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.

Primary outcomes

  1. Hearth rate

    Time frame: 30 minutes

    hearth rate of the infant in 1 minutes

  2. respiratory rate

    Time frame: 30 minutes

    respiratory rate of the infant in 1 minutes

  3. O2 saturation

    Time frame: 30 minutes

    O2 saturation of the infant

  4. body temperature

    Time frame: 30 minutes

    body temperature of the infant

  5. duration of crying

    Time frame: 30 minutes

    duration of crying of the infant

  6. Neonatal Infant Pain Scale

    Time frame: 30 minutes

    The total score on the NIPS pain scale ranges from 0 to 7. Scores higher than 3 indicate the presence of pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru UYGUR, MSc

CONTACT

[email protected]

05336822564

Çağrı ÇÖVENER ÖZÇELİK, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Effect of Two Different Kangaroo Care Interventions on Pain Level During Heel Prick Procedure in Neonates Receiving Phototherapy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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