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

May 13, 2026 updated by: Zeynep Aközlü, PhD, Maltepe University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zeynep Aközlü, MSc, PhD(c)
  • Phone Number: 5346651842
  • Email: zakozlu@gmail.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Istanbul Provincial Directorate of Health Kanuni Sultan Suleyman Training and Research Hospital
      • Istanbul, Turkey (Türkiye)
        • Istanbul University-Cerrahpasa (IUC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Classic kangaroo mother care position group (control group)
Experimental: Lateral kangaroo mother care position group
Behavioral: Lateral Kangaroo Mother Care 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.
Experimental: Reverse kangaroo mother care position group
Behavioral: Reverse Kangaroo Mother Care Position
Newborns in the reverse kangaroo position group will be positioned vertically with their backs in contact with the mothers chest.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of crying
Time Frame: From the heel lancing until the end of the blood collection procedure
It will be measured in seconds.
From the heel lancing until the end of the blood collection procedure
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.
From the heel lancing until the end of the blood collection procedure
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.
Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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.
Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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.
Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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.
Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maltepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğba Erener Ercan, PhD, maltepe University
  • Study Director: Zeynep Aközlü, Istanbul University - Cerrahpasa
  • Study Chair: Seda Çağlar, PhD, Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/13-03
  • 125S107 (Other Identifier: TUBİTAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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