- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06626815
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- 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 Locations
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Istanbul, Turkey (Türkiye)
- Istanbul Provincial Directorate of Health Kanuni Sultan Suleyman Training and Research Hospital
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Istanbul, Turkey (Türkiye)
- Istanbul University-Cerrahpasa (IUC)
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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
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 |
Intervention / Treatment |
|---|---|
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No Intervention: Classic kangaroo mother care position group (control group)
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Experimental: Lateral kangaroo mother care position group
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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.
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Experimental: Reverse kangaroo mother care position group
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Newborns in the reverse kangaroo position group will be positioned vertically with their backs in contact with the mothers chest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of crying
Time Frame: From the heel lancing until the end of the blood collection procedure
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It will be measured in seconds.
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From the heel lancing until the end of the blood collection procedure
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Time taken for heel blood collection
Time Frame: From the heel lancing until the end of the blood collection procedure
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It will be measured in seconds.
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From the heel lancing until the end of the blood collection procedure
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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)
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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.
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Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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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.
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Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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Heart rate
Time Frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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It will be measured using a pulse oximeter.
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Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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Oxygen saturation
Time Frame: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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It will be measured using a pulse oximeter.
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Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
December 1, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
October 1, 2024
First Submitted That Met QC Criteria
October 2, 2024
First Posted (Actual)
October 4, 2024
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID 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.