Hammock Position and Nesting in the Neonatal Intensive Care Unit

NCT06209060 | Recruiting

• 1 other identifier: 2023/85-58
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.

Conditions

Behavior, Nesting; Behavior, Child

Keywords

position; comfort; behavior; hammock position; nesting; preterm

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.

Study Arms (2)

Hammock Position Group

EXPERIMENTAL

Babies in the hammock position group will be placed in a hammock created by the researchers inside the incubator.

Behavioral: Hammock Position

Nesting Group

EXPERIMENTAL

Babies in the nesting group will be placed in a nest created by the researchers within the incubator.

Behavioral: Nesting

Interventions

Hammock Position BEHAVIORAL

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.

Hammock Position Group

Nesting BEHAVIORAL

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.

Nesting Group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Nesting Behavior; Child Behavior; Behavior; Premature Birth

Condition Hierarchy (Ancestors)

Consummatory Behavior; Behavior, Animal; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Selmin Köse, PhD

  Biruni University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Erkut, PhD

CONTACT

+9053536110075; zeyneperkut@maltepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)