StressNCT07335263
Effects of Swaddling and Nesting on Pain and Stress in Newborns
A study testing swaddling and Nesting in people with Stress and Non Pharmacological Intervention, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of swaddling and cradling methods on pain and stress levels in newborn infants receiving respiratory support. Infants receiving respiratory support in the neonatal intensive care unit may experience stress and discomfort during treatment. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Stress, Non Pharmacological Intervention, Newborn Diseases
- What is being tested?
- swaddling and Nesting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2025to 13 Dec 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth week greater than 35 weeks and birth weight greater than 2000 grams
- Requirement for nasal CPAP/noninvasive mechanical ventilation
- Legal guardians' consent to participate in the study
- Postnatal diagnosis of transient tachypnea of the newborn
Who cannot join
- Mother:
- Taking cortisol-containing medication during the antenatal period
- Taking narcotics during the antenatal period
- Having chorioamnionitis
- Having a metabolic disorder (adrenal insufficiency, etc.)
- Newborn:
Show all 18Show fewer
- Amniotic fluid stained with meconium
- Being intubated
- Having an Apgar score below 6
- Receiving analgesic or narcotic drugs for sedation
- The newborn receiving cortisol-containing medication
- Being unable to obtain a saliva sample or the sample being contaminated with blood
- Signs of nasal injury during noninvasive mechanical ventilation
- Congenital defects (spina bifida, gastroschisis, etc.) that prevent positioning using the swaddling or cradling methods
- Resuscitation
- Cerebral hypoxia-ischemia
- Non-respiratory causes (congenital pneumonia, respiratory distress syndrome, congenital heart disease, hypocalcemia, persistent hypoglycemia, development of sepsis)
- Hypocalcemia (low calcium level detected in blood gas sample taken while establishing an intravenous line prior to nCPAP)
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
Kütahya Health Sciences University
Merkez, Kütahya
Canan Sümeyra Özyurt, PhD, +90 274 260 0043, canansumeyra.gun@ksbu.edu.tr
About this study
Official title: The Effect of Swaddling and Nesting Methods on Pain and Stress Levels in Newborns Undergoing Noninvasive Mechanical Ventilation
This study aims to investigate the effects of swaddling and cradling methods on pain and stress levels in newborn infants receiving respiratory support.
Infants receiving respiratory support in the neonatal intensive care unit may experience stress and discomfort during treatment. In this study, two different care methods that help infants feel more comfortable and secure will be scientifically compared. Only one of the Swaddling or Nesting methods will be applied to the newborns participating in the study. These methods are comfort-enhancing care practices routinely used in neonatal intensive care that do not harm the baby. The newborn's heart rate, respiratory rate, oxygen level, pain and stress symptoms will be closely and safely monitored by the healthcare team. A pain-free saliva sample will be collected to assess the newborn's stress level. It does not involve needles, does not hurt, and takes approximately 2 minutes. Pain and stress levels will be assessed in a multifaceted manner using clinical observation, physiological parameters, and saliva cortisol levels. The study aims to contribute to the strengthening of evidence-based non-pharmacological care practices in neonatal intensive care.
Read the detailed description
This study was designed to investigate the effect of swaddling and nesting methods on pain and stress levels in newborns receiving nasal CPAP. The study was planned to be randomized and experimental in nature. The study population will consist of all newborns requiring nasal CPAP/noninvasive mechanical ventilation in the neonatal intensive care unit of a city hospital. The study will consist of two intervention groups. A total of 100 newborn patients (Swaddling group = 50, Nesting group = 50) will be included in the study after obtaining consent from the parents of newborns diagnosed with transient tachypnea, born at 35 weeks of gestation or older, who are receiving nasal CPAP/noninvasive mechanical ventilator treatment in the NICU and meet the inclusion criteria of the study. Environmental conditions that could cause stress to newborns (noise, heat, lighting, etc.) will be kept at optimal levels. When placed on nCPAP, the infant will be placed in the supine position to better observe chest movements and breathing patterns. To ensure the patency of the infant's airway, a slight extension position will be achieved using neck rolls. Respiratory distress in newborns receiving nCPAP, stress due to positive air pressure, and pain caused by the pressure of the nasal cannula on the nostrils will be assessed by two researchers using the ALPS-Neo Neonatal Pain and Stress Assessment Scale (ALPS-Neo). In the swaddling group, saliva samples will be collected before the swaddling method is applied (t1), during application (t2), and 30 minutes after the swaddling method is applied (t3). Heart rate, respiratory rate, partial oxygen pressure values, pain and stress levels (ALPS-Neo) will be recorded by two researchers. In the Nesting Group, saliva samples will also be collected before the Nesting method is applied (t1), during application (t2), and 30 minutes after the wrapping method is applied (t3). Heart rate, respiratory rate, partial oxygen pressure values, pain and stress levels (ALPS-Neo) will be recorded by two researchers. The saliva sample collection process will be performed by removing the cotton roll from the inner tube and holding it by one end under the baby's tongue or in the corners of the mouth (2.5 cm) where saliva can be collected for approximately 2 minutes until the cotton is thoroughly saturated with saliva (0.012-3.000 ug/dL). The roll of cotton will be held by its dry end and the wet part will be placed back into the inner tube, the tube cap will be closed, and barcodes with the patient's name written on them will be affixed to each sample taken. The collected saliva samples will be numbered and stored at -20°C in the refrigerator in the neonatal intensive care unit. On the same day, they will be transferred to the research laboratory (KUYAM) under cold chain conditions with research permission, and the sample size in the study groups will be completed. They will be stored at -80°C until the ELISA study time. The saliva sample collection process will be performed by removing the cotton roll from the inner tube and holding it by one end under the baby's tongue or in the corners of the mouth (2.5 cm) where saliva can be collected for approximately 2 minutes until the cotton is thoroughly saturated with saliva (0.012-3.000 ug/dL). The entire ELISA study will be conducted at the Kütahya Health Sciences University Research Laboratory (KUYAM), and the collected samples will be blinded for the ELISA worker. Saliva samples will be centrifuged again at 1000 g for 2 minutes to remove mucins and other particulate matter that could interfere with antibody binding and affect the results. When all samples have reached room temperature, pipette 25 μL of standard and sample into each well of the 96-well plate included in the kit. Next, add 200 μL of assay diluent to the 96-well plate using a micropipette and incubate at room temperature for 1 hour at 500 rpm. After incubation is complete, wash 4 times with 300 μL of wash buffer. After washing is complete, add 200 μL of TMB Substrate Solution to each well containing the sample and standards and incubate at room temperature in the dark at 500 rpm for 25 minutes. After the incubation process is complete, 50 μL of reaction stop solution will be added to each well. At this point, the reaction in the wells will be observed to turn from green to yellow, and after all wells have turned yellow, a spectrophotometric measurement will be made at a wavelength of 450 nm. Total concentrations will be calculated from the absorbance values for standards and samples, and cortisol levels will be reported in μg/dL.
- Conditions
- Stress, Non Pharmacological Intervention, Newborn Diseases
- Being tested
- swaddling, Nesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swaddlingBehavioural
Saliva samples will be collected before the swaddling method is applied (t1), during application (5th minute) (t2), and 30 minutes after the swaddling method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers.
NestingBehavioural
Saliva samples will be collected before the nesting method is applied (t1), during application (5th minute) (t2), and 30 minutes after the nesting method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers.
| Study group | Role | What they receive |
|---|---|---|
| Swaddling Group | Experimental | Swaddling method, a soft-textured, 100% cotton, square-shaped (100×100 cm, 110 g) fabric blanket that does not irritate the newborn's skin will be used. The newborn will be placed on the blanket in a supine position, naked except for a diaper, with the top edge of the blanket aligned with the shoulders. The arms will be placed in an extension-adduction position and the upper body will be swaddled with the blanket. The lower section will be wrapped with the legs in flexion and abduction, leaving space at the bottom for the feet to move freely and ensuring that the wrapping is not too tight. The baby's head will be allowed to move freely. Receives: Behavioral: Nesting |
| Nesting Group | Experimental | Nesting method, swaddling devices covered with 100% cotton fabric, which support the intrauterine position and are routinely used in the neonatal intensive care unit, will be used. The swaddling device is confined with soft padding materials to support the baby's neck and body. The arms of the newborn placed in the supine position will be brought into the extension-adduction position and secured with soft elastic straps, and the baby's surroundings will be safely restricted. This method will ensure that the baby remains in a physiological and comfortable position. Receives: Behavioral: swaddling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining pain and stress scores in newborns based on measurement times
The ALPS-Neo Neonatal Pain and Stress Assessment Scale (ALPS-Neo) score was recorded by the researcher before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3). The ALPS-Neo is a 3-point Likert-type scale consisting of 5 items: the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made through observation. As the score increases, stress and pain increase. The assessment results indicate that a score of 3-5 points indicates mild pain and stress, while a score above 5 points indicates severe pain and stress.
Measured: before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start17 Feb 2025
- Primary completion6 Sep 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335263
- Sponsor's protocol ID
- 2025/01-29
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 28 Jul 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Swaddling and Nesting Methods on Pain and Stress Levels in Newborns Undergoing Noninvasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07335263
- Acronym / sponsor ID
- 2025/01-29
- Conditions
- Stress, Non Pharmacological Intervention, Newborn Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 6 Sep 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 13 Jan 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 study aims to investigate the effects of swaddling and cradling methods on pain and stress levels in newborn infants receiving respiratory support.
Infants receiving respiratory support in the neonatal intensive care unit may experience stress and discomfort during treatment. In this study, two different care methods that help infants feel more comfortable and secure will be scientifically compared. Only one of the Swaddling or Nesting methods will be applied to the newborns participating in the study. These methods are comfort-enhancing care practices routinely used in neonatal intensive care that do not harm the baby. The newborn's heart rate, respiratory rate, oxygen level, pain and stress symptoms will be closely and safely monitored by the healthcare team. A pain-free saliva sample will be collected to assess the newborn's stress level. It does not involve needles, does not hurt, and takes approximately 2 minutes. Pain and stress levels will be assessed in a multifaceted manner using clinical observation, physiological parameters, and saliva cortisol levels. The study aims to contribute to the strengthening of evidence-based non-pharmacological care practices in neonatal intensive care.
Detailed description
This study was designed to investigate the effect of swaddling and nesting methods on pain and stress levels in newborns receiving nasal CPAP. The study was planned to be randomized and experimental in nature. The study population will consist of all newborns requiring nasal CPAP/noninvasive mechanical ventilation in the neonatal intensive care unit of a city hospital. The study will consist of two intervention groups. A total of 100 newborn patients (Swaddling group = 50, Nesting group = 50) will be included in the study after obtaining consent from the parents of newborns diagnosed with transient tachypnea, born at 35 weeks of gestation or older, who are receiving nasal CPAP/noninvasive mechanical ventilator treatment in the NICU and meet the inclusion criteria of the study. Environmental conditions that could cause stress to newborns (noise, heat, lighting, etc.) will be kept at optimal levels. When placed on nCPAP, the infant will be placed in the supine position to better observe chest movements and breathing patterns. To ensure the patency of the infant's airway, a slight extension position will be achieved using neck rolls. Respiratory distress in newborns receiving nCPAP, stress due to positive air pressure, and pain caused by the pressure of the nasal cannula on the nostrils will be assessed by two researchers using the ALPS-Neo Neonatal Pain and Stress Assessment Scale (ALPS-Neo). In the swaddling group, saliva samples will be collected before the swaddling method is applied (t1), during application (t2), and 30 minutes after the swaddling method is applied (t3). Heart rate, respiratory rate, partial oxygen pressure values, pain and stress levels (ALPS-Neo) will be recorded by two researchers. In the Nesting Group, saliva samples will also be collected before the Nesting method is applied (t1), during application (t2), and 30 minutes after the wrapping method is applied (t3). Heart rate, respiratory rate, partial oxygen pressure values, pain and stress levels (ALPS-Neo) will be recorded by two researchers. The saliva sample collection process will be performed by removing the cotton roll from the inner tube and holding it by one end under the baby's tongue or in the corners of the mouth (2.5 cm) where saliva can be collected for approximately 2 minutes until the cotton is thoroughly saturated with saliva (0.012-3.000 ug/dL). The roll of cotton will be held by its dry end and the wet part will be placed back into the inner tube, the tube cap will be closed, and barcodes with the patient's name written on them will be affixed to each sample taken. The collected saliva samples will be numbered and stored at -20°C in the refrigerator in the neonatal intensive care unit. On the same day, they will be transferred to the research laboratory (KUYAM) under cold chain conditions with research permission, and the sample size in the study groups will be completed. They will be stored at -80°C until the ELISA study time. The saliva sample collection process will be performed by removing the cotton roll from the inner tube and holding it by one end under the baby's tongue or in the corners of the mouth (2.5 cm) where saliva can be collected for approximately 2 minutes until the cotton is thoroughly saturated with saliva (0.012-3.000 ug/dL). The entire ELISA study will be conducted at the Kütahya Health Sciences University Research Laboratory (KUYAM), and the collected samples will be blinded for the ELISA worker. Saliva samples will be centrifuged again at 1000 g for 2 minutes to remove mucins and other particulate matter that could interfere with antibody binding and affect the results. When all samples have reached room temperature, pipette 25 μL of standard and sample into each well of the 96-well plate included in the kit. Next, add 200 μL of assay diluent to the 96-well plate using a micropipette and incubate at room temperature for 1 hour at 500 rpm. After incubation is complete, wash 4 times with 300 μL of wash buffer. After washing is complete, add 200 μL of TMB Substrate Solution to each well containing the sample and standards and incubate at room temperature in the dark at 500 rpm for 25 minutes. After the incubation process is complete, 50 μL of reaction stop solution will be added to each well. At this point, the reaction in the wells will be observed to turn from green to yellow, and after all wells have turned yellow, a spectrophotometric measurement will be made at a wavelength of 450 nm. Total concentrations will be calculated from the absorbance values for standards and samples, and cortisol levels will be reported in μg/dL.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swaddling Group | Experimental | Behavioral: NestingSwaddling method, a soft-textured, 100% cotton, square-shaped (100×100 cm, 110 g) fabric blanket that does not irritate the newborn's skin will be used. The newborn will be placed on the blanket in a supine position, naked except for a diaper, with the top edge of the blanket aligned with the shoulders. The arms will be placed in an extension-adduction position and the upper body will be swaddled with the blanket. The lower section will be wrapped with the legs in flexion and abduction, leaving space at the bottom for the feet to move freely and ensuring that the wrapping is not too tight. The baby's head will be allowed to move freely. |
| Nesting Group | Experimental | Behavioral: swaddlingNesting method, swaddling devices covered with 100% cotton fabric, which support the intrauterine position and are routinely used in the neonatal intensive care unit, will be used. The swaddling device is confined with soft padding materials to support the baby's neck and body. The arms of the newborn placed in the supine position will be brought into the extension-adduction position and secured with soft elastic straps, and the baby's surroundings will be safely restricted. This method will ensure that the baby remains in a physiological and comfortable position. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth week greater than 35 weeks and birth weight greater than 2000 grams
- Requirement for nasal CPAP/noninvasive mechanical ventilation
- Legal guardians' consent to participate in the study
- Postnatal diagnosis of transient tachypnea of the newborn
Key exclusion criteria (18 listed)
- Taking cortisol-containing medication during the antenatal period
- Taking narcotics during the antenatal period
- Having chorioamnionitis
- Having a metabolic disorder (adrenal insufficiency, etc.)
- Amniotic fluid stained with meconium
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 |
|---|---|---|
| swaddlingSaliva samples will be collected before the swaddling method is applied (t1), during application (5th minute) (t2), and 30 minutes after the swaddling method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers. | Behavioural | Nesting Group |
| NestingSaliva samples will be collected before the nesting method is applied (t1), during application (5th minute) (t2), and 30 minutes after the nesting method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers. | Behavioural | Swaddling Group |
Primary outcome
Determining pain and stress scores in newborns based on measurement times
Time frame: before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)
The ALPS-Neo Neonatal Pain and Stress Assessment Scale (ALPS-Neo) score was recorded by the researcher before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3). The ALPS-Neo is a 3-point Likert-type scale consisting of 5 items: the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made through observation. As the score increases, stress and pain increase. The assessment results indicate that a score of 3-5 points indicates mild pain and stress, while a score above 5 points indicates severe pain and stress.
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 28 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing swaddling and Nesting in people with Stress and Non Pharmacological Intervention, run by Kutahya Health Sciences 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 4 inclusion and 18 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 28 Jul 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 Canan Sümeyra Özyurt, Asist. Prof. Dr., PHD (05458125720, canansumeyra.gun@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining pain and stress scores in newborns based on measurement times (time frame: before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)). 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 28 Jul 2026.