Hammock Position and Nesting in the Neonatal Intensive Care Unit

August 28, 2026 updated by: Zeynep Erkut, Maltepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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,
  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hammock Position Group
Babies in the hammock position group will be placed in a hammock created by the researchers inside the incubator.
Behavioral: Hammock Position
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.
Experimental: Nesting Group
Babies in the nesting group will be placed in a nest created by the researchers within the incubator.
Behavioral: Nesting
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
The researchers recorded the neonates' heart rate from the ECG monitor
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.
The researchers recorded the neonates' respiration rate from the ECG monitor
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.
The researchers recorded the neonates' oxygen saturation from the ECG monitor
5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maltepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Selmin Köse, PhD, Biruni University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/85-58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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