The Effect of Different Kangaroo Positions on Newborns During Heel Lancing

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• Conditions: Heel Lancing; Heel Lance Procedures; Kangaroo Mother Care; Skin to Skin Contact
• Interventions: Behavioral: Lateral Kangaroo Position; Behavioral: Reverse Kangaroo Position

• Registration Number: NCT06626815
• Lead Sponsor: Maltepe University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2024-11-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral kangaroo position group	Lateral Kangaroo Position	-
Reverse kangaroo position group	Reverse Kangaroo Position	-

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale - NIPS	Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 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.
Newborn Comfort Behavior Scale - COMFORTneo	Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 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.
Heart rate	Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)	It will be measured using a pulse oximeter.
Oxygen saturation	Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)	It will be measured using a pulse oximeter.
Duration of crying	From the heel lancing until the end of the blood collection procedure	It will be measured in seconds.
Time taken for heel blood collection	From the heel lancing until the end of the blood collection procedure	It will be measured in seconds.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa (IUC); 🇹🇷 Istanbul, Turkey