Behavior, NestingNCT06209060
Hammock Position and Nesting in the Neonatal Intensive Care Unit
A study testing Hammock Position and Nesting in people with Behavior, Nesting and Behavior, Child, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Behavior, Nesting, Behavior, Child
- What is being tested?
- Hammock Position and Nesting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Jul 2026
- 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 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm babies between 32-37 weeks of gestation
- The weight of the baby is 1500 grams and above,
- Postnatal age is 3 days or more,
- Preterm babies who have been in the Neonatal Intensive Care Unit for more than 24 hours,
- The baby is fed intermittently for more than 60 minutes,
- 30 minutes have passed since feeding,
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- Do not perform procedures such as peripheral vascular access, blood collection, or gastric tube placement on the baby within the last hour before being taken into the study,
- Not applying phototherapy to the baby,
- No problems with the central nervous system such as cranial bleeding, convulsion, hypertonia,
- The baby does not have any congenital anomalies or respiratory distress,
- The baby does not receive oxygen support and is not connected to a respirator.
Who cannot join
- Babies younger than 32 weeks of gestation and older than 37 weeks of gestation
- The baby's weight is below 1500 grams,
- Postnatal age is less than 3 days,
- Preterm babies who have been in the Neonatal Intensive Care Unit for less than 24 hours,
- The baby is fed at intervals of less than 60 minutes,
- Less than 30 minutes have passed since feeding,
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- Performing procedures such as peripheral vascular access, blood collection, and gastric tube placement on the baby within the last hour before being taken into the study,
- Applying phototherapy to the baby,
- Having a problem with the central nervous system such as cranial hemorrhage, convulsion, hypertonia,
- Presence of the baby's congenital anomaly or respiratory distress,
- The baby receives oxygen support and is connected to a respirator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hammock Position and Nesting on the Comfort Level and Physiological Parameters of Preterm Babies
This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.
Read the detailed description
The study will be conducted with the randomized controlled experimental method. The sample size determined in the sample width analysis was determined as 72 babies (hammock position group: 36 babies; nesting group: 36 babies) with an effect size of 0.6, alpha error probability of 0.05, and a power value of 0.80. A sample of 72 preterm neonates will be randomly assigned into two equal groups. Neonates in the hammock position group will be placed in a hammock created by the researchers inside the incubator. Neonates in the nesting group will be placed in a nest created by the researchers within the incubator. Babies will be fed and their diapers changed before being positioned. These positions will be applied to babies for one hour every day for 5 consecutive days. Before positioning, the pulse oximeter device will be attached to the baby's foot, and its physiological parameters will be evaluated by remaining on the baby's foot for the duration of the positioning. During the one-hour position, no invasive procedures or diaper changes will be performed on the babies, the baby will not be touched, only observation will be made. The babies' comfort levels will be evaluated with the 'Newborn Comfort Behavior Scale' 5 minutes before positioning, at the 2nd, 20th, 40th, 60th minutes of positioning and 5 minutes after positioning, and their physiological parameters will be measured. The babies' comfort level will be evaluated independently by two observers.
- Conditions
- Behavior, Nesting, Behavior, Child
- Being tested
- Hammock Position, Nesting
- Keywords
- position, comfort, behavior, hammock position, nesting, preterm
- Medical subject headings
- Nesting Behavior, Child Behavior, Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hammock PositionBehavioural
Researchers will make a hammock by using a soft rectangular cotton cloth with ropes that pass through the circular openings of the incubator and are tied on the upper part of it. Babies will be placed in this hammock in a supine position with their extremities in the midline. The spine of the preterm neonate will support while arms and knees are flexed. Additionally, a small rectangular roller will be placed between the cervical and scapular region of the newborn in the hammock position to ensure that no hyperflexion or hyperextension position of the head occurs, which may impair respiratory function.
NestingBehavioural
In the nesting group, a nest will be made using rolls prepared with materials such as towels and blankets, and the baby will be placed in this nest. The baby's head and body will be positioned on the same axis, its extremities will be positioned in the midline, and its hands will be positioned close to its face.
| Study group | Role | What they receive |
|---|---|---|
| Hammock Position Group | Experimental | Babies in the hammock position group will be placed in a hammock created by the researchers inside the incubator. Receives: Behavioral: Hammock Position |
| Nesting Group | Experimental | Babies in the nesting group will be placed in a nest created by the researchers within the incubator. Receives: Behavioral: Nesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Level
The preterm babies' comfort levels will be determined using the Newborn Comfort Behavior Scale (COMFORTneo). COMFORTneo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In addition to determining comfort, the Newborn Comfort Behavior Scale allows nurses to evaluate the baby's pain and distress. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. COMFORTneo score values under 13 indicate no pain or stress, values between 14 and 21 indicate moderate pain or stress, and values between 22 and 30 indicate severe pain or stress.
Measured: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Secondary outcomes (3)
Heart Rate
The researchers recorded the neonates' heart rate from the ECG monitor
Measured: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Respiration Rate
The researchers recorded the neonates' respiration rate from the ECG monitor
Measured: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Oxygen Saturation
The researchers recorded the neonates' oxygen saturation from the ECG monitor
Measured: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Nov 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, NestingStudies 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Maltepe University
- Investigators
- Selmin Köse, PhD, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209060
- Sponsor's protocol ID
- 2023/85-58
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2024
- Last updated
- 31 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hammock Position and Nesting on the Comfort Level and Physiological Parameters of Preterm Babies
- ClinicalTrials.gov ID
- NCT06209060
- Acronym / sponsor ID
- 2023/85-58
- Conditions
- Behavior, Nesting, Behavior, Child
- Keywords
- position, comfort, behavior, hammock position, nesting, preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.
Detailed description
The study will be conducted with the randomized controlled experimental method. The sample size determined in the sample width analysis was determined as 72 babies (hammock position group: 36 babies; nesting group: 36 babies) with an effect size of 0.6, alpha error probability of 0.05, and a power value of 0.80. A sample of 72 preterm neonates will be randomly assigned into two equal groups. Neonates in the hammock position group will be placed in a hammock created by the researchers inside the incubator. Neonates in the nesting group will be placed in a nest created by the researchers within the incubator. Babies will be fed and their diapers changed before being positioned. These positions will be applied to babies for one hour every day for 5 consecutive days. Before positioning, the pulse oximeter device will be attached to the baby's foot, and its physiological parameters will be evaluated by remaining on the baby's foot for the duration of the positioning. During the one-hour position, no invasive procedures or diaper changes will be performed on the babies, the baby will not be touched, only observation will be made. The babies' comfort levels will be evaluated with the 'Newborn Comfort Behavior Scale' 5 minutes before positioning, at the 2nd, 20th, 40th, 60th minutes of positioning and 5 minutes after positioning, and their physiological parameters will be measured. The babies' comfort level will be evaluated independently by two observers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hammock Position Group | Experimental | Behavioral: Hammock PositionBabies in the hammock position group will be placed in a hammock created by the researchers inside the incubator. |
| Nesting Group | Experimental | Behavioral: NestingBabies in the nesting group will be placed in a nest created by the researchers within the incubator. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Preterm babies between 32-37 weeks of gestation
- The weight of the baby is 1500 grams and above,
- Postnatal age is 3 days or more,
- Preterm babies who have been in the Neonatal Intensive Care Unit for more than 24 hours,
- The baby is fed intermittently for more than 60 minutes,
Key exclusion criteria (11 listed)
- Babies younger than 32 weeks of gestation and older than 37 weeks of gestation
- The baby's weight is below 1500 grams,
- Postnatal age is less than 3 days,
- Preterm babies who have been in the Neonatal Intensive Care Unit for less than 24 hours,
- The baby is fed at intervals of less than 60 minutes,
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 |
|---|---|---|
| Hammock PositionResearchers will make a hammock by using a soft rectangular cotton cloth with ropes that pass through the circular openings of the incubator and are tied on the upper part of it. Babies will be placed in this hammock in a supine position with their extremities in the midline. The spine of the preterm neonate will support while arms and knees are flexed. Additionally, a small rectangular roller will be placed between the cervical and scapular region of the newborn in the hammock position to ensure that no hyperflexion or hyperextension position of the head occurs, which may impair respiratory function. | Behavioural | Hammock Position Group |
| NestingIn the nesting group, a nest will be made using rolls prepared with materials such as towels and blankets, and the baby will be placed in this nest. The baby's head and body will be positioned on the same axis, its extremities will be positioned in the midline, and its hands will be positioned close to its face. | Behavioural | Nesting Group |
Primary outcome
Comfort Level
Time frame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
The preterm babies' comfort levels will be determined using the Newborn Comfort Behavior Scale (COMFORTneo). COMFORTneo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In addition to determining comfort, the Newborn Comfort Behavior Scale allows nurses to evaluate the baby's pain and distress. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. COMFORTneo score values under 13 indicate no pain or stress, values between 14 and 21 indicate moderate pain or stress, and values between 22 and 30 indicate severe pain or stress.
3 secondary outcomes
Heart Rate
Time frame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Respiration Rate
Time frame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Oxygen Saturation
Time frame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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.
Selmin Köse, PhD principal investigator
Biruni 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 Hammock Position and Nesting in people with Behavior, Nesting and Behavior, Child, run by Maltepe 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 11 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 31 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?
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?
Comfort Level (time frame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.). 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 31 Aug 2026.