The Effect of Different Kangaroo Positions on Newborns During Heel Lancing

NCT06626815 | Not Yet Recruiting

• 1 other identifier: 2024/13-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

reverse kangaroo mother care; lateral kangaroo mother care; kangaroo positions

Outcome Measures

Primary Outcomes (6)

• Neonatal Infant Pain Scale - NIPS

  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.

  Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)

• Newborn Comfort Behavior Scale - COMFORTneo

  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.

  Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)

• Heart rate

  It will be measured using a pulse oximeter.

  Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)

• Oxygen saturation

  It will be measured using a pulse oximeter.

  Before the procedure (-5 minutes), during the procedure (0 minutes), and after the procedure (1 and 5 minutes)

• Duration of crying

  It will be measured in seconds.

  From the heel lancing until the end of the blood collection procedure

• Time taken for heel blood collection

  It will be measured in seconds.

  From the heel lancing until the end of the blood collection procedure

Study Arms (3)

Classic kangaroo position group (control group)

NO INTERVENTION

Lateral kangaroo position group

EXPERIMENTAL

Behavioral: Lateral Kangaroo Position

Reverse kangaroo position group

EXPERIMENTAL

Behavioral: Reverse Kangaroo Position

Interventions

Lateral Kangaroo 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.

Lateral kangaroo position group

Reverse Kangaroo Position BEHAVIORAL

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

Reverse kangaroo position group

Eligibility Criteria

• Age: 48 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maltepe University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa (IUC)

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Zeynep Aközlü

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Seda Çağlar, PhD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Tuğba Erener Ercan, PhD

  Maltepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Aközlü, MSc, PhD(c)

CONTACT

5346651842; zakozlu@gmail.com

Seda Çağlar, PhD

CONTACT

5352792047; sedacaglars@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)