Neonatal PainNCT07125690
Effect of Two Non-pharmacological Method on Pain, Stress Procedure Duration in Newborn
A study testing local heat application, oral sucrose and mixed group in people with Neonatal Pain and Non-Pharmacological Pain Management, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned as a prospective, single-blind, randomized controlled experimental study matched according to gestational age, gender, and birth weight, to determine the effects of local heat application and oral sucrose use during heel prick blood collection on pain, stress, procedure duration, and… Read more about this study
- Who is it for?
- Ages 3 to 31 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Pain, Non-Pharmacological Pain Management
- What is being tested?
- local heat application, oral sucrose and mixed group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2023to 3 Jun 2024
- 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 3 to 31 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 38-42 weeks gestational age,
- birth weight ≥ 2500 g,
- stable vital signs,
- no congenital anomalies,
- no congenital illnesses at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS), and sepsis,
- no intracranial hemorrhage,
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- not taking any medications other than antibiotics and vitamin supplements,
- not fed or changed within 30 minutes before the heel prick,
- not taking opioids or sedatives within 4 hours before the heel prick,
- not undergoing any painful procedures at least one hour before the heel prick,
- newborns whose mothers gave verbal and written informed consent
Who cannot join
- Newborns who exhibited signs of infection (gastroenteritis, sepsis, etc.) during the study,
- Blood collection was not possible on the first attempt,
- Newborns whose mothers wished to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Local Heat Application and Oral Sucrose Use Before Heel Pick Collection on Pain, Stress, and Procedure Duration in Newborns
This study is planned as a prospective, single-blind, randomized controlled experimental study matched according to gestational age, gender, and birth weight, to determine the effects of local heat application and oral sucrose use during heel prick blood collection on pain, stress, procedure duration, and physiological parameters of newborns.
Read the detailed description
Non-pharmacological methods are important alternatives for managing pain caused by minimally invasive procedures performed on newborns. Applying local heat to the heel, one of the non-pharmacological methods that can be used to reduce pain during heel prick in newborns, suppresses pain escalation by activating the gate-control mechanism, reduces pain, stimulates sensory receptors, and induces vasodilation. It also reduces ischemic pain, promotes the removal of metabolic waste, increases endorphin release, inhibits muscle contraction, reduces the effects of pressure, and provides pain relief for newborns.
Another non-pharmacological method used for pain management in newborns is oral sucrose administration. Used as an analgesic in minor invasive procedures, sucrose activates the endogenous opioid system by stimulating the sense of taste. Oral sucrose administration is an easily administered, proven, readily available, inexpensive, and rapidly effective method.
Authorities have an important role to play in minimizing the negative effects of various invasive procedures and cutting procedures, and protecting the baby from the short- and long-term effects of pain. Natural, economical, and easily curative methods for reducing pain during heel punctures include sucrose administration and topical heat application to the heel, among the herbal solutions offered by Mothers and Organics.Various non-pharmacological methods have been investigated in the literature for their effects on pain during heel prick blood sampling, and the positive effects of sucrose injection and heat application to the heel have also been reported. However, studies have generally focused on the use of sucrose injection and local heat application to the heel alone for pain reduction. There is no study evaluating their combined use in the same sample and comparing their effects.Therefore, this study aims to determine the effects of local heat application to the heel and oral sucrose administration during heel prick blood collection on the pain, stress, physiological parameters, and procedure duration of newborns.
- Conditions
- Neonatal Pain, Non-Pharmacological Pain Management
- Being tested
- local heat application, oral sucrose, mixed group
- Keywords
- neonatal, procedural pain, heel lancing, local heat applications, oral sucrose
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local heat applicationOther
The newborns included in this group received local dry heat application 5 minutes before the heel prick procedure, with the newborn in the supine position. Local dry heat was applied using a thermometer heated with water between 40 and 45˚C. The temperature of the water inside the thermometer was measured before application. The thermometer was applied to the sole of the newborn's right foot. Contact with bare skin was prevented, and the thermometer was used in a protective cover.
oral sucroseOther
In accordance with the Neonatal Pain and Treatment Guidelines, a total of 1 ml of sucrose at a 24% concentration recommended for full-term infants was prepared in a syringe. It was administered to the anterior tongue 2 minutes before the heel prick
mixed groupOther
Newborns included in the combined intervention group received local dry heat with a thermometer heated with water at 40-45˚C 5 minutes before blood collection, with the infant in the supine position. At the third minute of the local heating, 1 ml of 24% sucrose was applied to the anterior tongue over 1 minute. A stopwatch was used to monitor the procedure times.
| Study group | Role | What they receive |
|---|---|---|
| Local Heat Application to the Heel | Active comparator | The newborns included in this group received local dry heat application 5 minutes before the heel prick procedure, with the newborn in the supine position. Local dry heat was applied using a thermometer heated with water between 40 and 45˚C. The temperature of the water inside the thermometer was measured before application. The thermometer was applied to the sole of the newborn's right foot. Contact with bare skin was prevented, and the thermometer was used in a protective cover. Receives: Other: local heat application |
| Oral Sucrose Administration | Active comparator | In accordance with the Neonatal Pain and Treatment Guidelines, a total of 1 ml of sucrose at a 24% concentration recommended for full-term infants was prepared in a syringe. It was administered to the anterior tongue 2 minutes before the heel prick. Receives: Other: oral sucrose |
| Local Heat and Oral Sucrose Application to the Heel | Active comparator | Newborns included in the combined intervention group received local dry heat with a thermometer heated with water at 40-45˚C 5 minutes before blood collection, with the infant in the supine position. At the third minute of the local heating, 1 ml of 24% sucrose was applied to the anterior tongue over 1 minute. A stopwatch was used to monitor the procedure times. Receives: Other: mixed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALPS-Neo Pain and Stress Assessment Scale
The ALP-Neo performance is a three-point Likert-type scale consisting of five items: the subject's facial expression, breathing pattern, extremity tone, hand and foot activity, and activity level. Measurements are made through observation. The resulting score reflects increased stress and pain (3-5 points = mild pain and stress; >5 points = severe pain and stress).
Measured: 6 month
Newborn Infant Pain Scale (NIPS)
The scale consists of five behavioral parameters, including facial expression, crying, breathing pattern, arm and leg movements, and alertness, and one physiological parameter that tracks breathing pattern. Each behavior except crying is scored from 0 to 1, and the crying parameter is scored from 0, 1, and 2. The NIPS scores range from 0 to 7, with 0-2 indicating no pain, 3-4 indicating moderate pain, and >4 indicating severe pain. Cronbach's alpha coefficients for the scale were calculated as 0.95, 0.87, and 0.88 before, during, and after the intervention, respectively.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start11 Dec 2023
- Primary completion11 Dec 2023
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The process will be explained using the consent forms distributed to births that meet the inclusion criteria, and written consent will be obtained from the families. A Newborn and Family Identifying Information Form was first completed for the babies to be included in the study.For all groups to be included in the study, before the heel blood was taken, the Newborn Infant Pain Scale (NIPS), ALPS-Neo and physiological parameters were recorded on video with the babies' entire bodies visible, starting 6 minutes before the procedure, continuing during the procedure and ending 2 minutes after the procedure.The heel prick blood collection procedure was performed by the same healthcare professional each time, with the babies in the same position, and the data collection was performed by the researcher.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA GUL TAMER, TC Erciyes University
- Investigators
- fatma gul tamer, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125690
- Sponsor's protocol ID
- ErciyesU.FGTamer.01
- Status last verified
- Dec 2023
- First submitted
- 9 Aug 2025
- Last updated
- 15 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Heat Application and Oral Sucrose Use Before Heel Pick Collection on Pain, Stress, and Procedure Duration in Newborns
- ClinicalTrials.gov ID
- NCT07125690
- Acronym / sponsor ID
- ErciyesU.FGTamer.01
- Conditions
- Neonatal Pain, Non-Pharmacological Pain Management
- Keywords
- neonatal, procedural pain, heel lancing, local heat applications, oral sucrose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 15 Aug 2025 (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 study is planned as a prospective, single-blind, randomized controlled experimental study matched according to gestational age, gender, and birth weight, to determine the effects of local heat application and oral sucrose use during heel prick blood collection on pain, stress, procedure duration, and physiological parameters of newborns.
Detailed description
Non-pharmacological methods are important alternatives for managing pain caused by minimally invasive procedures performed on newborns. Applying local heat to the heel, one of the non-pharmacological methods that can be used to reduce pain during heel prick in newborns, suppresses pain escalation by activating the gate-control mechanism, reduces pain, stimulates sensory receptors, and induces vasodilation. It also reduces ischemic pain, promotes the removal of metabolic waste, increases endorphin release, inhibits muscle contraction, reduces the effects of pressure, and provides pain relief for newborns.
Another non-pharmacological method used for pain management in newborns is oral sucrose administration. Used as an analgesic in minor invasive procedures, sucrose activates the endogenous opioid system by stimulating the sense of taste. Oral sucrose administration is an easily administered, proven, readily available, inexpensive, and rapidly effective method.
Authorities have an important role to play in minimizing the negative effects of various invasive procedures and cutting procedures, and protecting the baby from the short- and long-term effects of pain. Natural, economical, and easily curative methods for reducing pain during heel punctures include sucrose administration and topical heat application to the heel, among the herbal solutions offered by Mothers and Organics.Various non-pharmacological methods have been investigated in the literature for their effects on pain during heel prick blood sampling, and the positive effects of sucrose injection and heat application to the heel have also been reported. However, studies have generally focused on the use of sucrose injection and local heat application to the heel alone for pain reduction. There is no study evaluating their combined use in the same sample and comparing their effects.Therefore, this study aims to determine the effects of local heat application to the heel and oral sucrose administration during heel prick blood collection on the pain, stress, physiological parameters, and procedure duration of newborns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The process will be explained using the consent forms distributed to births that meet the inclusion criteria, and written consent will be obtained from the families. A Newborn and Family Identifying Information Form was first completed for the babies to be included in the study.For all groups to be included in the study, before the heel blood was taken, the Newborn Infant Pain Scale (NIPS), ALPS-Neo and physiological parameters were recorded on video with the babies' entire bodies visible, starting 6 minutes before the procedure, continuing during the procedure and ending 2 minutes after the procedure.The heel prick blood collection procedure was performed by the same healthcare professional each time, with the babies in the same position, and the data collection was performed by the researcher.
| Arm | Type | Receives |
|---|---|---|
| Local Heat Application to the Heel | Active comparator | Other: local heat applicationThe newborns included in this group received local dry heat application 5 minutes before the heel prick procedure, with the newborn in the supine position. Local dry heat was applied using a thermometer heated with water between 40 and 45˚C. The temperature of the water inside the thermometer was measured before application. The thermometer was applied to the sole of the newborn's right foot. Contact with bare skin was prevented, and the thermometer was used in a protective cover. |
| Oral Sucrose Administration | Active comparator | Other: oral sucroseIn accordance with the Neonatal Pain and Treatment Guidelines, a total of 1 ml of sucrose at a 24% concentration recommended for full-term infants was prepared in a syringe. It was administered to the anterior tongue 2 minutes before the heel prick. |
| Local Heat and Oral Sucrose Application to the Heel | Active comparator | Other: mixed groupNewborns included in the combined intervention group received local dry heat with a thermometer heated with water at 40-45˚C 5 minutes before blood collection, with the infant in the supine position. At the third minute of the local heating, 1 ml of 24% sucrose was applied to the anterior tongue over 1 minute. A stopwatch was used to monitor the procedure times. |
Who may qualify
- Ages
- 3 to 31 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 38-42 weeks gestational age,
- birth weight ≥ 2500 g,
- stable vital signs,
- no congenital anomalies,
- no congenital illnesses at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS), and sepsis,
Key exclusion criteria (3 listed)
- Newborns who exhibited signs of infection (gastroenteritis, sepsis, etc.) during the study,
- Blood collection was not possible on the first attempt,
- Newborns whose mothers wished to withdraw from the study
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 |
|---|---|---|
| local heat applicationThe newborns included in this group received local dry heat application 5 minutes before the heel prick procedure, with the newborn in the supine position. Local dry heat was applied using a thermometer heated with water between 40 and 45˚C. The temperature of the water inside the thermometer was measured before application. The thermometer was applied to the sole of the newborn's right foot. Contact with bare skin was prevented, and the thermometer was used in a protective cover. | Other | Local Heat Application to the Heel |
| oral sucroseIn accordance with the Neonatal Pain and Treatment Guidelines, a total of 1 ml of sucrose at a 24% concentration recommended for full-term infants was prepared in a syringe. It was administered to the anterior tongue 2 minutes before the heel prick | Other | Oral Sucrose Administration |
| mixed groupNewborns included in the combined intervention group received local dry heat with a thermometer heated with water at 40-45˚C 5 minutes before blood collection, with the infant in the supine position. At the third minute of the local heating, 1 ml of 24% sucrose was applied to the anterior tongue over 1 minute. A stopwatch was used to monitor the procedure times. | Other | Local Heat and Oral Sucrose Application to the Heel |
Primary outcome
ALPS-Neo Pain and Stress Assessment Scale
Time frame: 6 month
The ALP-Neo performance is a three-point Likert-type scale consisting of five items: the subject's facial expression, breathing pattern, extremity tone, hand and foot activity, and activity level. Measurements are made through observation. The resulting score reflects increased stress and pain (3-5 points = mild pain and stress; >5 points = severe pain and stress).
Newborn Infant Pain Scale (NIPS)
Time frame: 6 month
The scale consists of five behavioral parameters, including facial expression, crying, breathing pattern, arm and leg movements, and alertness, and one physiological parameter that tracks breathing pattern. Each behavior except crying is scored from 0 to 1, and the crying parameter is scored from 0, 1, and 2. The NIPS scores range from 0 to 7, with 0-2 indicating no pain, 3-4 indicating moderate pain, and >4 indicating severe pain. Cronbach's alpha coefficients for the scale were calculated as 0.95, 0.87, and 0.88 before, during, and after the intervention, respectively.
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 Aug 2025.
- 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.
fatma gul tamer principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local heat application, oral sucrose and mixed group in people with Neonatal Pain and Non-Pharmacological Pain Management, run by TC Erciyes 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 11 inclusion and 3 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 Aug 2025. 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?
ALPS-Neo Pain and Stress Assessment Scale (time frame: 6 month). The study lists 2 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 Aug 2025.