Heel LancingNCT06626815
The Effect of Different Kangaroo Mother Care Positions on Newborns During Heel Lancing
A study testing Lateral Kangaroo Mother Care Position and Reverse Kangaroo Mother Care Position in people with Heel Lancing and Heel Lance Procedures, run by Maltepe University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Heel Lancing, Heel Lance Procedures, Kangaroo Mother Care
- What is being tested?
- Lateral Kangaroo Mother Care Position and Reverse Kangaroo Mother Care Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Provincial Directorate of Health Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
Istanbul University-Cerrahpasa (IUC)
Istanbul
About this study
Official title: 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.
- Being tested
- Lateral Kangaroo Mother Care Position, Reverse Kangaroo Mother Care Position
- Keywords
- reverse kangaroo mother care, lateral kangaroo mother care, kangaroo positions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Kangaroo Mother Care PositionBehavioural
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 Mother Care PositionBehavioural
Newborns in the reverse kangaroo position group will be positioned vertically with their backs in contact with the mothers chest.
| Study group | Role | What they receive |
|---|---|---|
| Classic kangaroo mother care position group (control group) | No intervention | Not described |
| Lateral kangaroo mother care position group | Experimental | Not described Receives: Behavioral: Lateral Kangaroo Mother Care Position |
| Reverse kangaroo mother care position group | Experimental | Not described Receives: Behavioral: Reverse Kangaroo Mother Care Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
Heart rate
It will be measured using a pulse oximeter.
Measured: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
Oxygen saturation
It will be measured using a pulse oximeter.
Measured: Before the procedure (-3rd minutes), during the procedure (0 minutes), and after the procedure (10th second, 1st and 5th minutes)
Duration of crying
It will be measured in seconds.
Measured: From the heel lancing until the end of the blood collection procedure
Time taken for heel blood collection
It will be measured in seconds.
Measured: From the heel lancing until the end of the blood collection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Dec 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel LancingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Zeynep Aközlü, PhD, Maltepe University
- Investigators
- Zeynep Aközlü, Study director, Istanbul University - CerrahpasaSeda Çağlar, PhD, Study chair, Istanbul University - CerrahpasaTuğba Erener Ercan, PhD, Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626815
- Sponsor's protocol ID
- 2024/13-03
- Other IDs
- 125S107
- Status last verified
- May 2026
- First submitted
- 1 Oct 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Kangaroo Mother Care Positions Given During Heel Lance Procedure on Newborns Pain, Comfort, and Physiological Parameters
- ClinicalTrials.gov ID
- NCT06626815
- Acronym / sponsor ID
- 2024/13-03
- Keywords
- reverse kangaroo mother care, lateral kangaroo mother care, kangaroo positions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classic kangaroo mother care position group (control group) | No intervention | – |
| Lateral kangaroo mother care position group | Experimental | Behavioral: Lateral Kangaroo Mother Care Position |
| Reverse kangaroo mother care position group | Experimental | Behavioral: Reverse Kangaroo Mother Care Position |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Kangaroo Mother Care PositionNewborns in the lateral kangaroo position group will be positioned diagonally on their mothers chests, with their heads placed between the mothers breast and collarbone. | Behavioural | Lateral kangaroo mother care position group |
| Reverse Kangaroo Mother Care PositionNewborns in the reverse kangaroo position group will be positioned vertically with their backs in contact with the mothers chest. | Behavioural | Reverse kangaroo mother care position group |
Primary outcome
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.
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.
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.
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.
Duration of crying
Time frame: From the heel lancing until the end of the blood collection procedure
It will be measured in seconds.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Aközlü study director
Istanbul University - Cerrahpasa
Seda Çağlar, PhD study chair
Istanbul University - Cerrahpasa
Tuğba Erener Ercan, PhD principal investigator
Maltepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Kangaroo Mother Care Position and Reverse Kangaroo Mother Care Position in people with Heel Lancing and Heel Lance Procedures, run by Maltepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.