Clinical trial NCT06626815: The Effect of Different Kangaroo Positions on Newborns During Heel Lancing
Official title: The Effect of Different Kangaroo Positions Given During Heel Lance Procedure on Newborns Pain, Comfort, and Physiological Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heel Lancing
Heel Lance Procedures
Kangaroo Mother Care
Skin to Skin Contact
Keywords: reverse kangaroo mother care
lateral kangaroo mother care
kangaroo positions
Lead sponsor: Maltepe University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2024-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria

* Born between 38-42 weeks of gestation
* Delivered via cesarean section
* 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 48-72 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

Primary outcomes:
measure: Neonatal Infant Pain Scale - NIPS
timeFrame: Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)
measure: Newborn Comfort Behavior Scale - COMFORTneo
timeFrame: Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)
measure: Heart rate
timeFrame: Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)
measure: Oxygen saturation
timeFrame: Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)
measure: Duration of crying
timeFrame: From the heel lancing until the end of the blood collection procedure
measure: Time taken for heel blood collection
timeFrame: From the heel lancing until the end of the blood collection procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa (IUC)
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Zeynep Aközlü
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Seda Çağlar, PhD
role: STUDY_CHAIR
affiliation: Maltepe University
name: Tuğba Erener Ercan, PhD
role: PRINCIPAL_INVESTIGATOR
References: