Clinical trial NCT06209060: Hammock Position and Nesting in the Neonatal Intensive Care Unit
Official title: The Effect of Hammock Position and Nesting on the Comfort Level and Physiological Parameters of Preterm Babies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior, Nesting
Behavior, Child
Keywords: position
comfort
behavior
hammock position
nesting
preterm
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort Level
timeFrame: 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:
measure: Heart Rate
timeFrame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
measure: Respiration Rate
timeFrame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
measure: Oxygen Saturation
timeFrame: 5 minutes before positioning the neonate, at the 2nd, 20th, 40th, 60th minute of positioning the neonate, 5 minutes after positioning the neonate.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University
Study officials:
affiliation: Biruni University
name: Selmin Köse, PhD
role: PRINCIPAL_INVESTIGATOR
References: