Newborn PainNESTINGNCT07748520
Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns
A study testing Nesting in people with Newborn Pain and Newborn Stress, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section. Read more about this study
- Who is it for?
- Ages Up to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Newborn Pain, Newborn Stress, Breastfeeding Success in Newborns
- What is being tested?
- Nesting
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.
- Born by cesarean section.
- Term newborn (gestational age between 37+0 and 41+6 weeks).
- Birth weight between 2,500 g and 4,000 g.
- Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).
- No acute or chronic medical conditions.
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- No congenital anomalies.
- No requirement for endotracheal intubation, resuscitation, or admission to the neonatal intensive care unit (NICU).
- Scheduled to receive the first intramuscular injection after birth.
Who cannot join
- Multiple birth (e.g., twins or higher-order multiples).
- Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.
- Withdrawal of parental consent at any time during the study.
- Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.
- Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.
- Delayed mother-newborn reunion due to maternal general anesthesia or prolonged sedation following spinal or epidural anesthesia.
- Delayed transfer of the newborn to the mother because of prolonged surgery, intraoperative complications, or delayed postoperative stabilization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli Darıca Farabi Training and Research Hospital
Darıca, Kocaeli
Emine Nur Çalımlı Celep, Msc, +90 506 126 48 03, enurcalimli@gmail.com
Sevil İnal, Prof. Dr.
About this study
Official title: The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
This randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section. A total of 112 newborns will be randomly assigned in a 1:1 ratio to either a nesting intervention group or a routine care control group. Newborns in the intervention group will receive nesting until the first intramuscular injection, whereas those in the control group will receive routine neonatal care. Pain, stress level, physiological parameters, settling time, and breastfeeding success will be evaluated using validated assessment tools. The findings are expected to provide evidence regarding the effectiveness of nesting as a simple, safe, and non-pharmacological intervention for reducing procedural pain and stress in newborns while supporting breastfeeding success.
Read the detailed description
Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.
Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.
Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.
The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.
- Being tested
- Nesting
- Keywords
- Nesting, Term Newborn, Cesarean Section, Intramuscular Injection, Newborn Pain, Newborn Stress, Breastfeeding Success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NestingBehavioural
Nesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection. The intervention aims to reduce procedural pain and stress and improve breastfeeding success.
| Study group | Role | What they receive |
|---|---|---|
| Nesting Group | Experimental | Term newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection. Pain, stress level, and breastfeeding success will be assessed using validated outcome measures. Receives: Behavioral: Nesting |
| Standard Care Group | No intervention | Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention. Pain, stress level, and breastfeeding success will be assessed using the same outcome measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Pain
Pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The pain/agitation component consists of five behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater pain.
Measured: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Neonatal Stress Level
Neonatal stress will be assessed using the Neonatal Stress Scale. The scale consists of eight behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 16. Higher scores indicate greater neonatal stress.
Measured: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Secondary outcomes (4)
Heart Rate
Heart rate will be measured in beats per minute (bpm) to evaluate the newborn's physiological response to intramuscular injection. Higher heart rate values indicate a greater physiological response to procedural stress.
Measured: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Respiratory Rate
Respiratory rate will be measured in breaths per minute (breaths/min) to evaluate the newborn's physiological response to intramuscular injection. Higher respiratory rate values indicate a greater physiological response to procedural stress.
Measured: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%) to evaluate the newborn's physiological response to intramuscular injection. Higher SpO₂ values indicate better oxygenation.
Measured: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Breastfeeding Success
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT). The BBAT consists of four items (positioning, attachment, sucking, and swallowing), each scored from 0 to 2. Total scores range from 0 to 8, with higher scores indicating better breastfeeding effectiveness.
Measured: At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Nur Çalımlı Celep, Istanbul University - Cerrahpasa
- Investigators
- Sevil İnal, Prof. Dr., Principal investigator, Istanbul University-Cerrahpasa, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748520
- Sponsor's protocol ID
- NESTING-2025-09
- Acronym
- NESTING
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
- ClinicalTrials.gov ID
- NCT07748520
- Acronym / sponsor ID
- NESTING / NESTING-2025-09
- Keywords
- Nesting, Term Newborn, Cesarean Section, Intramuscular Injection, Newborn Pain, Newborn Stress, Breastfeeding Success
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Aug 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 randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section. A total of 112 newborns will be randomly assigned in a 1:1 ratio to either a nesting intervention group or a routine care control group. Newborns in the intervention group will receive nesting until the first intramuscular injection, whereas those in the control group will receive routine neonatal care. Pain, stress level, physiological parameters, settling time, and breastfeeding success will be evaluated using validated assessment tools. The findings are expected to provide evidence regarding the effectiveness of nesting as a simple, safe, and non-pharmacological intervention for reducing procedural pain and stress in newborns while supporting breastfeeding success.
Detailed description
Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.
Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.
Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.
The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesting Group | Experimental | Behavioral: NestingTerm newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection. Pain, stress level, and breastfeeding success will be assessed using validated outcome measures. |
| Standard Care Group | No intervention | –Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention. Pain, stress level, and breastfeeding success will be assessed using the same outcome measures. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.
- Born by cesarean section.
- Term newborn (gestational age between 37+0 and 41+6 weeks).
- Birth weight between 2,500 g and 4,000 g.
- Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).
Key exclusion criteria (7 listed)
- Multiple birth (e.g., twins or higher-order multiples).
- Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.
- Withdrawal of parental consent at any time during the study.
- Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.
- Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.
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 |
|---|---|---|
| NestingNesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection. The intervention aims to reduce procedural pain and stress and improve breastfeeding success. | Behavioural | Nesting Group |
Primary outcome
Neonatal Pain
Time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The pain/agitation component consists of five behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater pain.
Neonatal Stress Level
Time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Neonatal stress will be assessed using the Neonatal Stress Scale. The scale consists of eight behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 16. Higher scores indicate greater neonatal stress.
4 secondary outcomes
Heart Rate
Time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Respiratory Rate
Time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Peripheral Oxygen Saturation
Time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
Breastfeeding Success
Time frame: At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Sevil İnal, Prof. Dr. principal investigator
Istanbul University-Cerrahpasa, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nesting in people with Newborn Pain and Newborn Stress, run by Istanbul University - Cerrahpasa 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 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Nur Çalımlı Celep, MSc (+90 506 126 48 03, enurcalimli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Pain (time frame: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.). 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 5 Aug 2026.