Comfort in NeonatesNCT07580677
The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort
A study testing breastfeeding and Kangaroo Care in people with Comfort in Neonates and Kangaroo Care, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. Read more about this study
- Who is it for?
- Ages 24 hours to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Comfort in Neonates, Kangaroo Care, Breast-feeding
- What is being tested?
- breastfeeding and Kangaroo Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 1 Jan 2026
- 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 hours to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental consent must be obtained in accordance with the participant information and consent form
- The baby must be term, between 37-42 weeks gestation
- Birth weight must be 2500 grams or more
- The mother must be present with the baby
- The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed)
- There must be no condition that prevents pain assessment (neuromotor developmental delay, etc.)
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- The baby must not have undergone any invasive procedures other than routine interventions
- The baby must have been born by cesarean section
- The mother must speak and understand Turkish fluently
Who cannot join
- Pre-procedure NIPS score of 3 or higher
- Lack of parental consent based on participant information and consent form
- Newborn born before 37 weeks of gestation
- Birth weight under 2500 grams
- Unstable general condition
- Vaginal delivery
Show all 9Show fewer
- Invasive procedures performed on the baby other than routine procedures
- Failure to obtain heel prick blood on the first attempt
- Mother not speaking Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet Üniversitesi Sağlık Hizmetleri Uygulama ve Araştırma Hastanesinde Kadın Hastalıkları Obs-tetri servisi
Sivas, Merkez, 58030
About this study
Official title: The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort: A Randomızed Controlled Study
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to.
Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain.
Read more
H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain.
H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level.
H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level.
H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level.
H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level.
The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026.
The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns.
The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.
Read the detailed description
Heel prick blood sampling is one of the invasive procedures frequently performed in divorces. Ensuring the proper continuation and survival of fractures that occur during this procedure is of great importance. Nurses have responsibilities regarding the identification of cooling and comfort components of equipment, the operation of appropriate interventions using this equipment, and the maintenance of basic comfort enhancement. While there are limited industrial studies on the combined use of breastfeeding and kangaroo care for pain relief, no studies have been found that evaluate pain and temperature together. There is a need for current reports on monitoring, prevention, and treatment related to pain control in preterm and term newborns monitored both in and out of hospitals. In this context, the aim of our study is to determine the duration of pain and temperature associated with breastfeeding and kangaroo care applied before heel prick blood sampling in newborns.
- Conditions
- Comfort in Neonates, Kangaroo Care, Breast-feeding, Pain in Newborns
- Being tested
- breastfeeding, Kangaroo Care, Standard Care (in control arm)
- Keywords
- Kangaroo Care, Breastfeeding, Comfort of The Newborn, Pain of The Newborn
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeedingOther
Before the heel prick blood test, a newborn information form and a parent identification form will be completed. Parents will be given information about breastfeeding, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.
Kangaroo CareOther
Before the procedure, a newborn information form and a parent identification form will be completed. Parents will be given information about kangaroo care, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be provided with kangaroo care for 30 minutes before the heel prick blood sample is taken. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the procedure. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.
Standard Care (in control arm)Other
No intervention will be performed. Routine hospital procedure will be applied.Physiological parameters, NIPS (Neuro-Visual Imaging System), and comfort behavior will be evaluated before, during, and after the procedure. Additionally, the newborn's crying duration will be recorded using a stopwatch during the procedure. The newborn will also be recorded on camera during the procedure for evaluation by a blind evaluator.
| Study group | Role | What they receive |
|---|---|---|
| This is the group where the baby is breastfed before the heel prick blood test. In this group, the e | Experimental | Breastfeeding Group (Group 1) Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated before, during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test. Receives: Other: breastfeeding |
| This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab | Experimental | Kangaroo Care Group (Group 2) Each baby in the group will be given 30 minutes of kangaroo care before heel prick blood is taken. Physiological parameters, NIPS (Neural Network Imaging System) scores, and comfort behavior will be evaluated before, during, and after the procedure. Receives: Other: Kangaroo Care |
| This is the group that receives standard care. | Experimental | Control Group (Group 3) Physiological parameters, NIPS (Neuroprocedure Testing System), and comfort behavior will be evaluated before, during, and after the procedure. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature.
Newborn Infant Pain Scale Assessment Form: The NIPS Form is used to assess pain and consists of six behavioral responses: facial expression, emission pattern, arms, fullness, and volume. Crying performance is given three points (0-1-2), while other behaviors are given only two points (0-1). The total score is calculated based on the Neonatal Pain Scale, with a maximum score of 7 and a minimum score of 0. A NIPS score between 0-2 indicates no pain and requires no intervention. A pain score between 3-4 indicates moderate acoustic pain, and complementary and alternative interventions are applied. A pain score above four suggests complementary and alternative Neonatal Comfort Behavior Scale (NICS): Each item on the scale is scored from 1 to 5. The overall score is used for evaluation. The lowest possible score on the Newborn Comfort Behavior Scale is 6, and the highest is 30. A total score between 9-13 indicates that the baby is comfortable, while a score between 14-30 indicates that th
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 Feb 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comfort in NeonatesStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University Hospital
- Responsible party
- Principal investigator, BÜŞRA SERTAKAN BAŞPINAR, Cumhuriyet University
- Investigators
- FERDAĞ YILDIRIM, Study director, SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK HİZMETLERİ MESLEK YÜKSEKOKULUEMİNE ALTUN YILMAZ, Study director, SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ HEMŞİRELİK BÖLÜMÜ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580677
- Sponsor's protocol ID
- CU-SBF-BSB-01
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT07580677
- Acronym / sponsor ID
- CU-SBF-BSB-01
- Conditions
- Comfort in Neonates, Kangaroo Care, Breast-feeding, Pain in Newborns
- Keywords
- Kangaroo Care, Breastfeeding, Comfort of The Newborn, Pain of The Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University Hospital
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 12 May 2026 (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.
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to.
Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain.
H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain.
H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level.
H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level.
H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level.
H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level.
The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026.
The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns.
The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.
Detailed description
Heel prick blood sampling is one of the invasive procedures frequently performed in divorces. Ensuring the proper continuation and survival of fractures that occur during this procedure is of great importance. Nurses have responsibilities regarding the identification of cooling and comfort components of equipment, the operation of appropriate interventions using this equipment, and the maintenance of basic comfort enhancement. While there are limited industrial studies on the combined use of breastfeeding and kangaroo care for pain relief, no studies have been found that evaluate pain and temperature together. There is a need for current reports on monitoring, prevention, and treatment related to pain control in preterm and term newborns monitored both in and out of hospitals. In this context, the aim of our study is to determine the duration of pain and temperature associated with breastfeeding and kangaroo care applied before heel prick blood sampling in newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| This is the group where the baby is breastfed before the heel prick blood test. In this group, the e | Experimental | Other: breastfeedingBreastfeeding Group (Group 1) Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated before, during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test. |
| This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab | Experimental | Other: Kangaroo CareKangaroo Care Group (Group 2) Each baby in the group will be given 30 minutes of kangaroo care before heel prick blood is taken. Physiological parameters, NIPS (Neural Network Imaging System) scores, and comfort behavior will be evaluated before, during, and after the procedure. |
| This is the group that receives standard care. | Experimental | Other: Standard Care (in control arm)Control Group (Group 3) Physiological parameters, NIPS (Neuroprocedure Testing System), and comfort behavior will be evaluated before, during, and after the procedure. |
Who may qualify
- Ages
- 24 hours to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Parental consent must be obtained in accordance with the participant information and consent form
- The baby must be term, between 37-42 weeks gestation
- Birth weight must be 2500 grams or more
- The mother must be present with the baby
- The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed)
Key exclusion criteria (9 listed)
- Pre-procedure NIPS score of 3 or higher
- Lack of parental consent based on participant information and consent form
- Newborn born before 37 weeks of gestation
- Birth weight under 2500 grams
- Unstable general condition
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 |
|---|---|---|
| breastfeedingBefore the heel prick blood test, a newborn information form and a parent identification form will be completed. Parents will be given information about breastfeeding, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator. | Other | This is the group where the baby is breastfed before the heel prick blood test. In this group, the e |
| Kangaroo CareBefore the procedure, a newborn information form and a parent identification form will be completed. Parents will be given information about kangaroo care, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be provided with kangaroo care for 30 minutes before the heel prick blood sample is taken. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the procedure. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator. | Other | This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab |
| Standard Care (in control arm)No intervention will be performed. Routine hospital procedure will be applied.Physiological parameters, NIPS (Neuro-Visual Imaging System), and comfort behavior will be evaluated before, during, and after the procedure. Additionally, the newborn's crying duration will be recorded using a stopwatch during the procedure. The newborn will also be recorded on camera during the procedure for evaluation by a blind evaluator. | Other | This is the group that receives standard care. |
Primary outcome
Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature.
Time frame: about a year
Newborn Infant Pain Scale Assessment Form: The NIPS Form is used to assess pain and consists of six behavioral responses: facial expression, emission pattern, arms, fullness, and volume. Crying performance is given three points (0-1-2), while other behaviors are given only two points (0-1). The total score is calculated based on the Neonatal Pain Scale, with a maximum score of 7 and a minimum score of 0. A NIPS score between 0-2 indicates no pain and requires no intervention. A pain score between 3-4 indicates moderate acoustic pain, and complementary and alternative interventions are applied. A pain score above four suggests complementary and alternative Neonatal Comfort Behavior Scale (NICS): Each item on the scale is scored from 1 to 5. The overall score is used for evaluation. The lowest possible score on the Newborn Comfort Behavior Scale is 6, and the highest is 30. A total score between 9-13 indicates that the baby is comfortable, while a score between 14-30 indicates that th
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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
FERDAĞ YILDIRIM study director
SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK HİZMETLERİ MESLEK YÜKSEKOKULU
EMİNE ALTUN YILMAZ study director
SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ HEMŞİRELİK BÖLÜMÜ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding and Kangaroo Care in people with Comfort in Neonates and Kangaroo Care, run by Cumhuriyet University at 1 site 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 9 inclusion and 9 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 12 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 1 site 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?
Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature. (time frame: about a year). 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 12 May 2026.