The Effect of Different Kangaroo Positions on Newborns During Heel Lancing

NCT ID: NCT06626815

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Classic kangaroo position group (control group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Lateral kangaroo position group

Group Type EXPERIMENTAL

Lateral Kangaroo Position

Intervention Type 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 position group

Group Type EXPERIMENTAL

Reverse Kangaroo Position

Intervention Type BEHAVIORAL

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

Interventions

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Lateral Kangaroo Position

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.

Intervention Type BEHAVIORAL

Reverse Kangaroo Position

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

48 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeynep Aközlü

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Seda Çağlar, PhD

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Tuğba Erener Ercan, PhD

Role: PRINCIPAL_INVESTIGATOR

Maltepe University

Locations

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Istanbul University-Cerrahpasa (IUC)

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Zeynep Aközlü, MSc, PhD(c)

Role: CONTACT

5346651842

Seda Çağlar, PhD

Role: CONTACT

5352792047

Facility Contacts

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Zeynep Aközlü, MSc, PhD(c)

Role: primary

5346651842

Other Identifiers

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2024/13-03

Identifier Type: -

Identifier Source: org_study_id

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