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Completed

NCT Number: NCT06626815

The Effect of Different Kangaroo Mother Care Positions on Newborns During Heel Lancing

Newborn screenings are crucial preventive health services within public health programs worldwide. In our country, as part of this program, heel blood is taken from newborns between the 48th and 72nd hours after birth, which causes pain and discomfort in newborns. Non-pharmacological methods are frequently utilized to relieve the pain caused by heel blood collection in newborns and to improve comfort during the procedure. One of these methods is kangaroo care, also known as skin-to-skin contact. Kangaroo care involves placing the baby in direct skin contact with the mother, which helps regulate the babys body temperature, calm the baby, and fosters bonding between mother and baby. This method, also described as human incubator care requires no special skills, is cost-effective, and is reported to have significant benefits in reducing procedural pain. In the literature, apart from the classic kangaroo position where the babys chest touches the mothers chest, there are studies describing alternative positions such as side kangaroo (kangaroo-supported diagonal flexion) and reverse kangaroo (supine kangaroo). The side kangaroo position differs from the classic kangaroo care in that the baby is held crosswise with its neck supported by the mother, allowing mother and baby to face each other. The reverse kangaroo position is a modified version of the classic kangaroo position, where the baby, wearing only a diaper, is placed upright with its back in contact with the mothers bare chest. Skin-to-skin contact during kangaroo care has a calming effect, reducing both physiological and behavioral pain responses in the baby. Therefore, it is thought that different kangaroo positions, which maintain skin-to-skin contact between the baby and the mother, may affect pain, comfort, physiological parameters, and crying durations during the heel blood collection procedure. Additionally, in cases where the classic kangaroo position cannot be used, these positions may serve as alternative methods. Upon reviewing national and international literature, no studies were found comparing the effectiveness of different kangaroo positions during heel blood collection in term newborns. Thus, this study aims to compare the effects of classic kangaroo, side kangaroo, and reverse kangaroo positions on pain, comfort, and physiological parameters (heart rate, oxygen saturation) in term newborns. Secondary outcomes of the study include evaluating the crying duration of newborns and the procedure duration for heel blood collection.

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Key information

Conditions

Heel Lancing Heel Lance Procedures Kangaroo Mother Care Skin to Skin Contact

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Provincial Directorate of Health Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Born between 37-42 weeks of gestation
  • Birth weight of 2500 grams or more
  • APGAR score over 6 at 5 minutes
  • Fed at least one hour prior to the procedure
  • Postnatal age of 24-72 hours
  • Successful heel blood collection performed in a single attempt
  • No invasive procedures performed after birth, except for vitamin K and Hepatitis B vaccination
  • Term newborns whose mothers have agreed to participate in the study

Exclusion criteria

for the Study

  • Genetic or congenital anomalies
  • Neurological, cardiological, or metabolic diseases
  • Requirement for respiratory support
  • Use of analgesics, sedatives, antiepileptics, or muscle relaxants within 24 hours prior to the procedure
  • Mothers with physical barriers preventing kangaroo care
  • Newborns whose mothers cannot communicate or do not speak Turkish

Treatment and study plan

Lateral Kangaroo Mother Care Position

Behavioral

Newborns in the lateral kangaroo position group will be positioned diagonally on their mothers chests, with their heads placed between the mothers breast and collarbone.

Reverse Kangaroo Mother Care Position

Behavioral

Newborns in the reverse kangaroo position group will be positioned vertically with their backs in contact with the mothers chest.

Primary outcomes

  1. Neonatal Infant Pain Scale - NIPS

    Time frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)

    It evaluates the baby's pain through six criteria: facial expression, crying, breathing pattern, arms, legs, and alertness. Five of these criteria are scored as either 0 or 1, while crying is scored from 0 to 2, ranging from good to poor. According to this scale, a newborn's pain is assessed on a total score where the highest score is 7 and the lowest is 0. If the pain score is between 0 and 2, it is considered no pain, and no intervention is needed. If the pain score is between 3 and 4, it is assessed as moderate pain, non-pharmacological interventions are applied, and pain is re-evaluated after 30 minutes. If the pain score is above 4, non-pharmacological interventions are conducted, possibly alongside pharmacological treatments, and pain is re-evaluated after 30 minutes.

  2. Newborn Comfort Behavior Scale - COMFORTneo

    Time frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)

    The Newborn Comfort Behavior Scale is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. For newborns receiving mechanical ventilator support, the "Respiratory Response" parameter is evaluated, while for those not on mechanical ventilator support, the "Crying" item is assessed.

  3. Heart rate

    Time frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)

    It will be measured using a pulse oximeter.

  4. Oxygen saturation

    Time frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)

    It will be measured using a pulse oximeter.

  5. Duration of crying

    Time frame: From the heel lancing until the end of the blood collection procedure

    It will be measured in seconds.

  6. Time taken for heel blood collection

    Time frame: From the heel lancing until the end of the blood collection procedure

    It will be measured in seconds.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

The Effect of Different Kangaroo Mother Care Positions Given During Heel Lance Procedure on Newborns Pain, Comfort, and Physiological Parameters

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
May 15, 2026

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

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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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