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Hammock Position and Nesting in the Neonatal Intensive Care Unit

M

Maltepe University

Status

Enrolling

Conditions

Behavior, Child
Behavior, Nesting

Treatments

Behavioral: Hammock Position
Behavioral: Nesting

Study type

Interventional

Funder types

Other

Identifiers

NCT06209060
2023/85-58

Details and patient eligibility

About

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

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

32 to 37 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Hammock Position Group
Experimental group
Description:
Babies in the hammock position group will be placed in a hammock created by the researchers inside the incubator.
Treatment:
Behavioral: Hammock Position
Nesting Group
Experimental group
Description:
Babies in the nesting group will be placed in a nest created by the researchers within the incubator.
Treatment:
Behavioral: Nesting

Trial contacts and locations

1

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Central trial contact

Zeynep Erkut, PhD

Data sourced from clinicaltrials.gov

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