Respiratory Disease of A NewbornNCT07077148
Swaddling and Facilitated Tucking During Nasal CPAP Application
A study testing Facilitated tucking and Swaddling in people with Respiratory Disease of A Newborn, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Disease of A Newborn
- What is being tested?
- Facilitated tucking and Swaddling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 30 Apr 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Those receiving nasal CPAP support,
- Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,
- Those without congenital anomalies,
- Those without a health problem that prevents positioning,
- Those without mental or neurological problems.
Who cannot join
- Those with pneumothorax,
- Newborns who received opioids or sedatives 4 hours before the procedure,
- Intubated newborns
- Newborns with a gestational age greater than 37 weeks
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
Recep Tayyip Erdogan University
Rize
Recep Tayyip Erdogan University ALTAY, +90 (464) 214 10 59, gamzegulaltay25@gmail.com
About this study
Official title: Effects of Swaddling and Facilitated Tucking on Newborn Pain, Stress and Comfort Levels During Nasal CPAP Application
This study was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. The study will be conducted in the neonatal intensive care unit of a Training and Research Hospital between May 2026 and December 2026. Newborns who meet the study criteria from the specified universe will constitute the sample of the study. "Newborn Identification Information Form", "ALPS Neo Neonatal Pain and Stress Assessment Scale", "Premature Baby Comfort Scale" and "Physiological Parameter Follow-up Form" will be used to collect data. will be used.
Read the detailed description
Type of Research: The research will be conducted in a randomized controlled experimental design.
Place and Time of the Research: The research will be conducted in the Neonatal Intensive Care Unit of a Training and Research Hospital between May 2026 and December 2026.
Research Universe and Sample: The universe of this research will consist of newborns receiving nasal CPAP support in the neonatal intensive care units of Recep Tayyip Erdoğan University Training and Research Hospital between May 2026 and December 2026. The newborns from the specified universe who meet the study criteria will constitute the sample of the study. The sample size in the research was calculated using the Gpower program. When the calculation was made with 3 groups (Experiment 1, Experiment 2, Control) and the effect size (d = 0.46), 5% margin of error (α = 0.05) and 99% power (1-β = 0.99), the sample size for each group was found to be 35 people. (Derince, 2016). In case of data loss, it was decided to collect data from a total of 114 newborns (38 fetal position, 38 swaddling, 38 control) by including a 10% spare sample in this number.
Randomization The randomization of the fetal position group, swaddling group and control groups will be determined with the research (https://www.randomizer.org/) program. In addition, after obtaining the ethics committee approval, the research registration number required for randomized controlled studies will be obtained from ClinicalTrials.gov.
Data Collection Tools to be Used in the Study: The Newborn Identification Information Form, ALPS Neo Newborn Pain and Stress Assessment Scale, Premature Baby Comfort Scale and Physiological Parameter Follow-up Form will be used to collect research data. The swaddle blanket used in the neonatal intensive care unit to swaddle babies and the towel support for fetal positioning and the baby care blankets used in the neonatal intensive care unit will be used as intervention tools in the study.
Nursing Interventions Nasal CPAP application applied to newborns will be performed in all groups (fetal position, swaddling and control group) in accordance with the clinical routine.
Data Collection The study will collect data from babies of parents who are admitted to the neonatal intensive care unit of a university hospital and who meet the inclusion criteria and agree to participate in the study. Since the "ALPS Neo Neonatal Pain and Stress Assessment Scale" and "Premature Infant Comfort Scale" to be used in data collection are observation-based scales, they will be filled out by both the researcher and the observer nurse. Data collection will be carried out before, during and after the procedure from each group (fetal position, swaddling and control group).
Ethical Principles of the Research In order to conduct the research, after receiving official institutional permission from the relevant institution, ethical approval will be obtained from the Ethics Committee of Recep Tayyip Erdoğan University Faculty of Medicine. The purpose of the study will be explained to the parents of newborns who meet the research group criteria, the questions asked will be answered and their verbal and written consent will be obtained. Parents will be informed that the data collected during the research will be processed confidentially and anonymously, will not be used outside the study in question and that they can withdraw from the study at any time. Since the research is based on the use of data obtained from humans and therefore, due to the necessity of protecting personal rights, the relevant ethical principles of "Informed Consent", "Voluntariness" and "Protection of Confidentiality" will be followed.
- Conditions
- Respiratory Disease of A Newborn
- Being tested
- Facilitated tucking, Swaddling
- Keywords
- facilitated tucking, Nasal cpap, swaddling, pain, comfort, stress
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated tuckingBehavioural
The upper and lower extremities of the newborns are taken to the midline and positioned in the womb.
SwaddlingBehavioural
The baby is swaddled using the cloths used in the neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated tucking group | Experimental | Newborns in this group will be placed in the facilitated tucking position during nasal CPAP application. Receives: Behavioral: Facilitated tucking |
| Swaddling group | Experimental | Newborns in this group will be swaddled during nasal CPAP application. Receives: Behavioral: Swaddling |
| Control group | No intervention | newborns in this group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALPS Neo Neonatal Pain and Stress Assessment Scale:
ALPS Neo Neonatal Pain and Stress Assessment Scale:
The "ALPS Neo Neonatal Pain and Stress Assessment Scale" was developed by Lundqvist et al. in 2014, based on the individualized developmental care of the newborn, in order to assess pain and stress in premature and term newborns (Lundqvist et al., 2014). This scale was adapted to Turkish in 2017 and its validity and reliability study was conducted by Ceylan and Bolışık. ALPS Neo is a 3-point Likert-type scale consisting of 5 items, namely "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made through observation. As the scores obtained increase, pain and stress in the newborn increase. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and 5 points and above indicate the presence of severe pain and stress" (Ceylan \& Bolışık, 2017).
Measured: 6 month
Premature Infant Comfort Scale
The comfort scale, developed by Ambuel and colleagues to measure the pain and stress levels of children aged 0-18, was later adapted by Monique and colleagues in 2007 for premature infants aged ≥28 and ≤37 weeks. The PBCS evaluates 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5 from bad to good. According to the PBCS, the baby's comfort is evaluated based on the total score. Accordingly, 35 indicates the lowest and 7 the highest comfort score. A high score obtained from the scale indicates a low comfort level (Küçük Alemdar and Güdücü Tüfekçi, 2015). The validity and reliability study of the scale was conducted by Alemdar and Tüfekçi in 2015 and the Cronbach Alpha value was 0.88.
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 posted22 Jul 2025
- Study start15 Jul 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Disease of A NewbornStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamzegül ALTAY, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077148
- Sponsor's protocol ID
- Gamze ALTAY
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aim is to share the research after it is published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swaddling and Facilitated Tucking on Newborn Pain, Stress and Comfort Levels During Nasal CPAP Application
- ClinicalTrials.gov ID
- NCT07077148
- Acronym / sponsor ID
- Gamze ALTAY
- Conditions
- Respiratory Disease of A Newborn
- Keywords
- facilitated tucking, Nasal cpap, swaddling, pain, comfort, stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Jul 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 was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. The study will be conducted in the neonatal intensive care unit of a Training and Research Hospital between May 2026 and December 2026. Newborns who meet the study criteria from the specified universe will constitute the sample of the study. "Newborn Identification Information Form", "ALPS Neo Neonatal Pain and Stress Assessment Scale", "Premature Baby Comfort Scale" and "Physiological Parameter Follow-up Form" will be used to collect data. will be used.
Detailed description
Type of Research: The research will be conducted in a randomized controlled experimental design.
Place and Time of the Research: The research will be conducted in the Neonatal Intensive Care Unit of a Training and Research Hospital between May 2026 and December 2026.
Research Universe and Sample: The universe of this research will consist of newborns receiving nasal CPAP support in the neonatal intensive care units of Recep Tayyip Erdoğan University Training and Research Hospital between May 2026 and December 2026. The newborns from the specified universe who meet the study criteria will constitute the sample of the study. The sample size in the research was calculated using the Gpower program. When the calculation was made with 3 groups (Experiment 1, Experiment 2, Control) and the effect size (d = 0.46), 5% margin of error (α = 0.05) and 99% power (1-β = 0.99), the sample size for each group was found to be 35 people. (Derince, 2016). In case of data loss, it was decided to collect data from a total of 114 newborns (38 fetal position, 38 swaddling, 38 control) by including a 10% spare sample in this number.
Randomization The randomization of the fetal position group, swaddling group and control groups will be determined with the research (https://www.randomizer.org/) program. In addition, after obtaining the ethics committee approval, the research registration number required for randomized controlled studies will be obtained from ClinicalTrials.gov.
Data Collection Tools to be Used in the Study: The Newborn Identification Information Form, ALPS Neo Newborn Pain and Stress Assessment Scale, Premature Baby Comfort Scale and Physiological Parameter Follow-up Form will be used to collect research data. The swaddle blanket used in the neonatal intensive care unit to swaddle babies and the towel support for fetal positioning and the baby care blankets used in the neonatal intensive care unit will be used as intervention tools in the study.
Nursing Interventions Nasal CPAP application applied to newborns will be performed in all groups (fetal position, swaddling and control group) in accordance with the clinical routine.
Data Collection The study will collect data from babies of parents who are admitted to the neonatal intensive care unit of a university hospital and who meet the inclusion criteria and agree to participate in the study. Since the "ALPS Neo Neonatal Pain and Stress Assessment Scale" and "Premature Infant Comfort Scale" to be used in data collection are observation-based scales, they will be filled out by both the researcher and the observer nurse. Data collection will be carried out before, during and after the procedure from each group (fetal position, swaddling and control group).
Ethical Principles of the Research In order to conduct the research, after receiving official institutional permission from the relevant institution, ethical approval will be obtained from the Ethics Committee of Recep Tayyip Erdoğan University Faculty of Medicine. The purpose of the study will be explained to the parents of newborns who meet the research group criteria, the questions asked will be answered and their verbal and written consent will be obtained. Parents will be informed that the data collected during the research will be processed confidentially and anonymously, will not be used outside the study in question and that they can withdraw from the study at any time. Since the research is based on the use of data obtained from humans and therefore, due to the necessity of protecting personal rights, the relevant ethical principles of "Informed Consent", "Voluntariness" and "Protection of Confidentiality" will be followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facilitated tucking group | Experimental | Behavioral: Facilitated tuckingNewborns in this group will be placed in the facilitated tucking position during nasal CPAP application. |
| Swaddling group | Experimental | Behavioral: SwaddlingNewborns in this group will be swaddled during nasal CPAP application. |
| Control group | No intervention | –newborns in this group will receive standard care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Those receiving nasal CPAP support,
- Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,
- Those without congenital anomalies,
- Those without a health problem that prevents positioning,
- Those without mental or neurological problems.
Key exclusion criteria (4 listed)
- Those with pneumothorax,
- Newborns who received opioids or sedatives 4 hours before the procedure,
- Intubated newborns
- Newborns with a gestational age greater than 37 weeks
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 |
|---|---|---|
| Facilitated tuckingThe upper and lower extremities of the newborns are taken to the midline and positioned in the womb. | Behavioural | Facilitated tucking group |
| SwaddlingThe baby is swaddled using the cloths used in the neonatal intensive care unit. | Behavioural | Swaddling group |
Primary outcome
ALPS Neo Neonatal Pain and Stress Assessment Scale:
Time frame: 6 month
ALPS Neo Neonatal Pain and Stress Assessment Scale: The "ALPS Neo Neonatal Pain and Stress Assessment Scale" was developed by Lundqvist et al. in 2014, based on the individualized developmental care of the newborn, in order to assess pain and stress in premature and term newborns (Lundqvist et al., 2014). This scale was adapted to Turkish in 2017 and its validity and reliability study was conducted by Ceylan and Bolışık. ALPS Neo is a 3-point Likert-type scale consisting of 5 items, namely "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made through observation. As the scores obtained increase, pain and stress in the newborn increase. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and 5 points and above indicate the presence of severe pain and stress" (Ceylan \& Bolışık, 2017).
Premature Infant Comfort Scale
Time frame: 6 month
The comfort scale, developed by Ambuel and colleagues to measure the pain and stress levels of children aged 0-18, was later adapted by Monique and colleagues in 2007 for premature infants aged ≥28 and ≤37 weeks. The PBCS evaluates 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5 from bad to good. According to the PBCS, the baby's comfort is evaluated based on the total score. Accordingly, 35 indicates the lowest and 7 the highest comfort score. A high score obtained from the scale indicates a low comfort level (Küçük Alemdar and Güdücü Tüfekçi, 2015). The validity and reliability study of the scale was conducted by Alemdar and Tüfekçi in 2015 and the Cronbach Alpha value was 0.88.
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 20 Jul 2026.
- Individual participant dataSharing planned: No. The aim is to share the research after it is published.
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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 Facilitated tucking and Swaddling in people with Respiratory Disease of A Newborn, run by Recep Tayyip Erdogan 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 5 inclusion and 4 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 20 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 Gamzegül ALTAY, PhD (+905456119296, gamzegulaltay25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALPS Neo Neonatal 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 20 Jul 2026.