PreTerm NeonateNCT06628232
Effect of Nursing Interventions on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns
A study testing pacifier with breast milk, heel heating and interventions combined in people with PreTerm Neonate, run by Namik Kemal University.
Trial summary
Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Read more about this study
- Who is it for?
- Ages 34 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- PreTerm Neonate
- What is being tested?
- pacifier with breast milk, heel heating and interventions combined
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 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 34 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother 18 years of age or older
- Mother is literate
- Whether the mother gives birth naturally or by caesarean section
- Uncomplicated pregnancy and birth history in mother
- Mother\'s voluntary participation in the study
- Preterm babies between 34 0/7-36 6/7 weeks
Show all 10Show fewer
- Prematurity at 34 0/7-36 6/7 weeks and weight appropriate for the week (Appropriate Gestational Age- AGA),
- The baby should be fed at least 1 hour in advance.
- It has been 1 hour since the last painful intervention on the baby.
- 6Heel blood should be taken 6 hours after taking analgesic, sedative and anticonvulsant medications.
Who cannot join
- The baby has a fever
- The baby receiving oxygen therapy,
- The baby receiving antibiotic treatment
- The baby has a congenital anomaly
- The baby having the bed side and heater underneath
- The baby receiving phototherapy,
- The baby is connected to a mechanical ventilator
- Babies whose blood was not collected on the first attempt
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Giving a Pacifier Dipped in Breast Milk, Heel Warming, and Applying Both Together on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns: Randomized Controlled Study.
Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Although many painful invasive procedures are usually performed on newborns in the NICU, the most common procedure is heel prick. Heel prick is a painful and stressful procedure for the newborn. Neonates do not respond to pain verbally; they respond physiologically, behaviorally and hormonally. Physiologic responses of preterm infants to pain include increased heart and respiratory rate, increased blood pressure and intracranial pressure, decreased oxygenation, and sweating of palms. Among the hormonal symptoms caused by stress in newborns, the most commonly used biochemical method is the measurement of cortisol level. It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level. This method is particularly preferred because saliva sampling is much less stressful.
Read the detailed description
Health professionals should be able to evaluate pain, reduce or eliminate pain in pain management of neonates in interventional applications. Pharmacologic and nonpharmacologic methods are used in pain management. When these methods are applied together, their effectiveness increases in pain related to invasive interventions. Pharmacologically, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, pacifier, oral sucrose, music, warm application, massage, therapeutic touch and positioning such as nesting, fetal positioning, swaddling, kangaroo care, rocking and holding.
In many studies, nonpharmacologic interventions have been applied and compared to reduce pain during heel prick in preterm newborns. In the routine of the clinic, heel prick blood collection from preterm newborns is performed by hugging the mother in her lap. The swaddling procedure for preterm newborns in the control group is recommended by the American Academy of Pediatrics. The swaddling method supports flexion and lateral posture, which is the developmental position of the newborn. With this position, the newborn comes to its position in the uterus, which is familiar to it, ensuring its physiological stability and improving its capacity. In a systematic review of 3396 participants, preterm newborns were calmed and immediately stabilized by kangaroo care, non-nutritive sucking and swaddling methods. Since these methods reduce pain and stress in preterm newborns, they are also reported to be included in "Individualized Supportive Developmental Care" practices.
Many studies have shown that giving pacifiers to newborns is effective in reducing pain. In addition, oral administration of breast milk alone, without breastfeeding, has been found to reduce pain during heel prick, nasopharyngeal aspiration, venipuncture and retinopathy examination in preterms. In the study conducted by Lan et al., breast milk was sniffed to the newborn during heel prick blood collection or tasted by dropping into the newborns mouth with a syringe. As a result, they reported that sniffing and plus tasting breast milk was effective in alleviating pain in newborns.
In the literature, it is emphasized that the pain that occurs during heel blood collection is closely related to the squeezing of the heel to collect blood, not during the needle insertion into the heel, and it is thought that keeping the newborn in an upright position during heel blood collection may facilitate blood flow through gravity and reduce the amount of squeezing required to obtain the sample. However, there are studies showing that heel warming is effective in reducing pain in newborns. It has been stated that with warm application to the heel -with the effect of vasodilation- fewer needling is performed in the heel, the amount of blood required for the procedure increases and the procedure is completed in a shorter time. It is predicted that the heel of the newborn will be squeezed less thanks to the warm application.
However, there is a very limited number of studies evaluating the effectiveness of different nonpharmacologic interventions during heel prick blood collection and measuring the stress marker cortisol. In addition, no study was found to investigate the effectiveness of other interventions (heel warming and giving a pacifier dipped in breast milk) in combination with wrapping among nonpharmacological interventions.
This study aimed to reduce pain during heel prick blood collection in preterm newborns by swaddling the baby in the mothers lap (control group), swaddling in the mothers lap together with giving a pacifier dipped in breast milk (pacifier with breast milk group), swaddling in the mother;s lap together with local dry heat application (heel heating group), and all interventions combined (swaddling in the mother;s lap together with giving a pacifier dipped in breast milk and heel heating-combined intervention group). In addition, it was planned as a randomized controlled experimental design to determine and compare the effects of these nursing interventions on the newborns physiological parameters, pain, salivary cortisol level, crying and procedure time.
Place and Time to Conduct the Research:
The research will be carried out between November 2024 and August 2025 in the Neonatal Intensive Care Unit of Tekirdag Namik Kemal University Hospital.
Population and Sample of the Study:
The study population will consist of infants who meet the inclusion criteria in the NICU of Tekirdağ Namik Kemal University between 01.11.2024-01.08.2025.
The sample size of the study was determined by power analysis. The study comparing non-nutritive suction, sucrose and combination interventions in heel prick blood collection in newborns with the control group was taken as a basis. According to the PIPP pain assessment scale used in the study, the 1st experimental group had a mean score of 9.3 ± 1.3, the 2nd experimental group 10.1 ± 2, the 3rd group 4.4 ± 1.5, and the control group 13.3 ± 1.6. In this study, it was determined that a total of 88 infants (22 in each group) should be included in the study in the sample number calculation made in the G*Power (3.1.9.2.) program with a 5% alpha margin of error (two-way) and 80% power, predicting that the PIPP score mean difference would have a large effect size (.95 large effect) (the effect size was found to be 2.74).
Randomization:
The sample will be randomly selected from the study population. In the study, randomization of premature newborns will be performed in a computer environment. The newborns to be subjected to heel prick blood collection were placed in groups with a randomized controlled method with 18 babies in each group. In the study, randomization was performed by entering the number of cases through the program whose URL address is http://www.randomizer.org.
Control (swaddling from mothers lap) 76, 41, 70, 15, 43, 38, 63, 2, 28, 55, 30, 35, 86, 61, 57, 84, 80, 74, 3, 24, 83, 71 Experiment 2 (swaddling from mothers lap + pacifier) 18, 79, 23, 19, 48, 47, 2, 61, 10, 73, 35, 74, 87, 38, 32, 5, 11, 12, 49, 80, 44, 55 Experiment 3 (swaddling from mothers lap + heel warming) 25, 17, 50, 7, 64, 35, 45, 11, 48, 82, 73, 23, 32, 54, 49, 74, 79, 3, 68, 56, 24, 81 Experiment 4 (swaddling from mothers lap + pacifier + heel warming) 57, 33, 21, 64, 13, 47, 56, 31, 41, 28, 43, 85, 20, 1, 75, 52, 11, 14, 3, 6, 38, 15
- Conditions
- PreTerm Neonate
- Being tested
- pacifier with breast milk, heel heating, interventions combined, Control
- Keywords
- preterm, leel prick, pain, salivary cortisol, nursing care
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacifier with breast milkOther
swaddling in the mother\'s lap together with giving a pacifier dipped in breast milk
heel heatingOther
swaddling in the mother\'s lap together with local dry heat application
interventions combinedOther
swaddling in the mother\'s lap together with giving a pacifier dipped in breast milk and heel heating
ControlOther
swaddling the baby in the mother\'s lap
| Study group | Role | What they receive |
|---|---|---|
| pacifier with breast milk group | Experimental | swaddling in the mother's lap together with giving a pacifier dipped in breast milk Receives: Other: pacifier with breast milk |
| heel heating group | Experimental | swaddling in the mother's lap together with local dry heat application Receives: Other: heel heating |
| combined intervention group | Experimental | all interventions combined (swaddling in the mother's lap together with giving a pacifier dipped in breast milk and heel heating Receives: Other: interventions combined |
| Control | Other | swaddling the baby in the mother's lap Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac apex beat (HRV)
HRV will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher.
Measured: Through study completion, an average of 1 year.
Oxygen saturation (SpO2)
SpO2 will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher. SpO2 will be recorded from this video recording.
Measured: Through study completion, an average of 1 year
Crying time
The baby crying time will be monitored and recorded 5 minutes before the heel prick and 5 minutes during the heel prick
Measured: Through study completion, an average of 1 year
Premature Infant Pain Profile Scale (PIPP-R)
The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolabial groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. In the scoring of the scale, items related to physiological and behavioral items are scored as 0,1,2,3 in each variable, reflecting the difference between baseline and treatment values. Items related to contextual items are scored as 3,2,1,0 before touching the baby. The babys pain is evaluated on a total score. Accordingly, the maximum score for newborns is 21. If the premature infant pain profile is between 0-6 points, the pain level in the infant is mild, between 7-12 points is moderate, and between 13-21 points is severe pain.
Each baby will be video monitored and recorded for 7-10 minutes before, during and after the procedure. This video recording will be evaluated and recorded according to the Premature Infant Pain Profile Scale.
Measured: Through study completion, an average of 1 year
Salivary cortisol level
Since cortisol shows circadian rhythm in premature infants, samples will be taken at the same time in the morning. Before taking saliva samples, the newborns mouth will be checked and oral care will be given with SF. Saliva samples will be collected with the Salimetrics Salivary Cortisol Kit by holding it in the cheek and sublingual cavity of the newborn for 1-2 minutes. The samples will be sent to the biochemistry laboratory of the research hospital. The samples will be analyzed for quantitative determination of cortisol by 2 biochemistry experts using standard procedures in the Biochemistry laboratory of TNKU Hospital.
Samples will be taken twice, both during the procedure and 25 minutes after the procedure (the highest cortisol level after pain in newborns is detected between 20-30 minutes after the procedure).
Measured: Through study completion, an average of 1 year
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 Nov 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreTerm NeonateStudies 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
- Model description
- Application of 3 different interventions to reduce pain during heel prick blood collection in newborns and comparison with the control group. Control Group 1 (swaddling from mother\'s lap) Experiment Group 2 (swaddling from mother\'s lap + pacifier) Experiment Group 3 (swaddling from mother\'s lap + heel warming) Experiment Group 4 (swaddling from mother\'s lap + pacifier + heel warming)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynem YILDIRIM BALKAN, Namik Kemal University
- Investigators
- Zeynem YILDIRIM BALKAN, Assist.Prof., Study director, Namik Kemal UniversityBirsen Mutlu, Assoc.Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628232
- Sponsor's protocol ID
- TNKU-Z.BALKAN-2
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.
PubMed 24476226Badiee Z, Nassiri Z, Armanian A. Cobedding of twin premature infants: calming effects on pain responses. Pediatr Neonatol. 2014 Aug;55(4):262-8. doi: 10.1016/j.pedneo.2013.11.008. Epub 2014 Mar 30.
PubMed 24694748
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Giving a Pacifier Dipped in Breast Milk, Heel Warming, and Applying Both Together on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06628232
- Acronym / sponsor ID
- TNKU-Z.BALKAN-2
- Conditions
- PreTerm Neonate
- Keywords
- preterm, leel prick, pain, salivary cortisol, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- 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.
Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Although many painful invasive procedures are usually performed on newborns in the NICU, the most common procedure is heel prick. Heel prick is a painful and stressful procedure for the newborn. Neonates do not respond to pain verbally; they respond physiologically, behaviorally and hormonally. Physiologic responses of preterm infants to pain include increased heart and respiratory rate, increased blood pressure and intracranial pressure, decreased oxygenation, and sweating of palms. Among the hormonal symptoms caused by stress in newborns, the most commonly used biochemical method is the measurement of cortisol level. It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level. This method is particularly preferred because saliva sampling is much less stressful.
Detailed description
Health professionals should be able to evaluate pain, reduce or eliminate pain in pain management of neonates in interventional applications. Pharmacologic and nonpharmacologic methods are used in pain management. When these methods are applied together, their effectiveness increases in pain related to invasive interventions. Pharmacologically, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, pacifier, oral sucrose, music, warm application, massage, therapeutic touch and positioning such as nesting, fetal positioning, swaddling, kangaroo care, rocking and holding.
In many studies, nonpharmacologic interventions have been applied and compared to reduce pain during heel prick in preterm newborns. In the routine of the clinic, heel prick blood collection from preterm newborns is performed by hugging the mother in her lap. The swaddling procedure for preterm newborns in the control group is recommended by the American Academy of Pediatrics. The swaddling method supports flexion and lateral posture, which is the developmental position of the newborn. With this position, the newborn comes to its position in the uterus, which is familiar to it, ensuring its physiological stability and improving its capacity. In a systematic review of 3396 participants, preterm newborns were calmed and immediately stabilized by kangaroo care, non-nutritive sucking and swaddling methods. Since these methods reduce pain and stress in preterm newborns, they are also reported to be included in "Individualized Supportive Developmental Care" practices.
Many studies have shown that giving pacifiers to newborns is effective in reducing pain. In addition, oral administration of breast milk alone, without breastfeeding, has been found to reduce pain during heel prick, nasopharyngeal aspiration, venipuncture and retinopathy examination in preterms. In the study conducted by Lan et al., breast milk was sniffed to the newborn during heel prick blood collection or tasted by dropping into the newborns mouth with a syringe. As a result, they reported that sniffing and plus tasting breast milk was effective in alleviating pain in newborns.
In the literature, it is emphasized that the pain that occurs during heel blood collection is closely related to the squeezing of the heel to collect blood, not during the needle insertion into the heel, and it is thought that keeping the newborn in an upright position during heel blood collection may facilitate blood flow through gravity and reduce the amount of squeezing required to obtain the sample. However, there are studies showing that heel warming is effective in reducing pain in newborns. It has been stated that with warm application to the heel -with the effect of vasodilation- fewer needling is performed in the heel, the amount of blood required for the procedure increases and the procedure is completed in a shorter time. It is predicted that the heel of the newborn will be squeezed less thanks to the warm application.
However, there is a very limited number of studies evaluating the effectiveness of different nonpharmacologic interventions during heel prick blood collection and measuring the stress marker cortisol. In addition, no study was found to investigate the effectiveness of other interventions (heel warming and giving a pacifier dipped in breast milk) in combination with wrapping among nonpharmacological interventions.
This study aimed to reduce pain during heel prick blood collection in preterm newborns by swaddling the baby in the mothers lap (control group), swaddling in the mothers lap together with giving a pacifier dipped in breast milk (pacifier with breast milk group), swaddling in the mother;s lap together with local dry heat application (heel heating group), and all interventions combined (swaddling in the mother;s lap together with giving a pacifier dipped in breast milk and heel heating-combined intervention group). In addition, it was planned as a randomized controlled experimental design to determine and compare the effects of these nursing interventions on the newborns physiological parameters, pain, salivary cortisol level, crying and procedure time.
Place and Time to Conduct the Research:
The research will be carried out between November 2024 and August 2025 in the Neonatal Intensive Care Unit of Tekirdag Namik Kemal University Hospital.
Population and Sample of the Study:
The study population will consist of infants who meet the inclusion criteria in the NICU of Tekirdağ Namik Kemal University between 01.11.2024-01.08.2025.
The sample size of the study was determined by power analysis. The study comparing non-nutritive suction, sucrose and combination interventions in heel prick blood collection in newborns with the control group was taken as a basis. According to the PIPP pain assessment scale used in the study, the 1st experimental group had a mean score of 9.3 ± 1.3, the 2nd experimental group 10.1 ± 2, the 3rd group 4.4 ± 1.5, and the control group 13.3 ± 1.6. In this study, it was determined that a total of 88 infants (22 in each group) should be included in the study in the sample number calculation made in the G*Power (3.1.9.2.) program with a 5% alpha margin of error (two-way) and 80% power, predicting that the PIPP score mean difference would have a large effect size (.95 large effect) (the effect size was found to be 2.74).
Randomization:
The sample will be randomly selected from the study population. In the study, randomization of premature newborns will be performed in a computer environment. The newborns to be subjected to heel prick blood collection were placed in groups with a randomized controlled method with 18 babies in each group. In the study, randomization was performed by entering the number of cases through the program whose URL address is http://www.randomizer.org.
Control (swaddling from mothers lap) 76, 41, 70, 15, 43, 38, 63, 2, 28, 55, 30, 35, 86, 61, 57, 84, 80, 74, 3, 24, 83, 71 Experiment 2 (swaddling from mothers lap + pacifier) 18, 79, 23, 19, 48, 47, 2, 61, 10, 73, 35, 74, 87, 38, 32, 5, 11, 12, 49, 80, 44, 55 Experiment 3 (swaddling from mothers lap + heel warming) 25, 17, 50, 7, 64, 35, 45, 11, 48, 82, 73, 23, 32, 54, 49, 74, 79, 3, 68, 56, 24, 81 Experiment 4 (swaddling from mothers lap + pacifier + heel warming) 57, 33, 21, 64, 13, 47, 56, 31, 41, 28, 43, 85, 20, 1, 75, 52, 11, 14, 3, 6, 38, 15
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Application of 3 different interventions to reduce pain during heel prick blood collection in newborns and comparison with the control group. Control Group 1 (swaddling from mother\'s lap) Experiment Group 2 (swaddling from mother\'s lap + pacifier) Experiment Group 3 (swaddling from mother\'s lap + heel warming) Experiment Group 4 (swaddling from mother\'s lap + pacifier + heel warming)
| Arm | Type | Receives |
|---|---|---|
| pacifier with breast milk group | Experimental | Other: pacifier with breast milkswaddling in the mother's lap together with giving a pacifier dipped in breast milk |
| heel heating group | Experimental | Other: heel heatingswaddling in the mother's lap together with local dry heat application |
| combined intervention group | Experimental | Other: interventions combinedall interventions combined (swaddling in the mother's lap together with giving a pacifier dipped in breast milk and heel heating |
| Control | Other | Other: Controlswaddling the baby in the mother's lap |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Mother 18 years of age or older
- Mother is literate
- Whether the mother gives birth naturally or by caesarean section
- Uncomplicated pregnancy and birth history in mother
- Mother\'s voluntary participation in the study
Key exclusion criteria (8 listed)
- The baby has a fever
- The baby receiving oxygen therapy,
- The baby receiving antibiotic treatment
- The baby has a congenital anomaly
- The baby having the bed side and heater underneath
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 |
|---|---|---|
| pacifier with breast milkswaddling in the mother\'s lap together with giving a pacifier dipped in breast milk | Other | pacifier with breast milk group |
| heel heatingswaddling in the mother\'s lap together with local dry heat application | Other | heel heating group |
| interventions combinedswaddling in the mother\'s lap together with giving a pacifier dipped in breast milk and heel heating | Other | combined intervention group |
| Controlswaddling the baby in the mother\'s lap | Other | Control |
Primary outcome
Cardiac apex beat (HRV)
Time frame: Through study completion, an average of 1 year.
HRV will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher.
Oxygen saturation (SpO2)
Time frame: Through study completion, an average of 1 year
SpO2 will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher. SpO2 will be recorded from this video recording.
Crying time
Time frame: Through study completion, an average of 1 year
The baby crying time will be monitored and recorded 5 minutes before the heel prick and 5 minutes during the heel prick
Premature Infant Pain Profile Scale (PIPP-R)
Time frame: Through study completion, an average of 1 year
The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolabial groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. In the scoring of the scale, items related to physiological and behavioral items are scored as 0,1,2,3 in each variable, reflecting the difference between baseline and treatment values. Items related to contextual items are scored as 3,2,1,0 before touching the baby. The babys pain is evaluated on a total score. Accordingly, the maximum score for newborns is 21. If the premature infant pain profile is between 0-6 points, the pain level in the infant is mild, between 7-12 points is moderate, and between 13-21 points is severe pain. Each baby will be video monitored and recorded for 7-10 minutes before, during and after the procedure. This video recording will be evaluated and recorded according to the Premature Infant Pain Profile Scale.
Salivary cortisol level
Time frame: Through study completion, an average of 1 year
Since cortisol shows circadian rhythm in premature infants, samples will be taken at the same time in the morning. Before taking saliva samples, the newborns mouth will be checked and oral care will be given with SF. Saliva samples will be collected with the Salimetrics Salivary Cortisol Kit by holding it in the cheek and sublingual cavity of the newborn for 1-2 minutes. The samples will be sent to the biochemistry laboratory of the research hospital. The samples will be analyzed for quantitative determination of cortisol by 2 biochemistry experts using standard procedures in the Biochemistry laboratory of TNKU Hospital. Samples will be taken twice, both during the procedure and 25 minutes after the procedure (the highest cortisol level after pain in newborns is detected between 20-30 minutes after the procedure).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Results publication: PubMed 24476226Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.
- Results publication: PubMed 24694748Badiee Z, Nassiri Z, Armanian A. Cobedding of twin premature infants: calming effects on pain responses. Pediatr Neonatol. 2014 Aug;55(4):262-8. doi: 10.1016/j.pedneo.2013.11.008. Epub 2014 Mar 30.
- 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.
Zeynem YILDIRIM BALKAN, Assist.Prof. study director
Namik Kemal University
Birsen Mutlu, Assoc.Prof. principal investigator
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing pacifier with breast milk, heel heating and interventions combined in people with PreTerm Neonate, run by Namik Kemal University.
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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynem YILDIRIM BALKAN, Assist.Prof. (+905073190958 ext. we dnt have US, zyildirim@nku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac apex beat (HRV) (time frame: Through study completion, an average of 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628232, which also lists 2 linked publications.
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 4 Oct 2024.