The Effect of Rocking Bed on Preterm Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-09-15

Brief Summary

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The study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rSO2).

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Detailed Description

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In most cultures, providing a newborn baby on the lap or in a rocking bed is mostly used to calm the baby. However, preterm babies who leave the uterus, which is their accustomed environment, in the early period, are positioned on a fixed bed such as an incubator or jeans in the NICU. These beds may reduce the infant's vestibular knowledge and the NICU environment may deprive infants of sensory stimuli. It has been suggested that because the vestibular system is one of the first systems to become functional, preterm infants may be more sensitive to stimulation of the vestibular system than other systems. When the studies were examined, it was seen that limited studies were conducted in the sample of preterm infants and the studies were not recent. Considering that babies are rocked in most cultures, it is thought that the evidence for the effects of the intervention on the baby is insufficient.

Conditions

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Preterm Preterm Birth Nurse's Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study was planned to be conducted in a randomized controlled crossover design. Infants meeting the inclusion criteria will be divided into two groups, group A and group B, according to block randomization. Groups were determined by drawing lots. (A= Rocking bed; B= Jeans) Accordingly, babies included in group A will be taken to the rocking bed first. Babies included in group B will be quoted first. Babies will be laid in these beds for an average of 2 hours. In cross-over design, a washout is recommended in order to control the carry over effect that may result from the interference. We assumed that the total time without interference would be sufficient to control the carryover effect, since the oscillation interference was only applied for half an hour in a two-hour sleep cycle, and there was routine maintenance and feeding cycles between measurements (average 20 min).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group: rocking bed group

Preterms in the intervention group will lie in a rocking bed for a consecutive two-hour period without treatment and invasive procedures. During 30 minutes of this period, the rocking bed will be in the rocking mode and will stop at the end of 30 minutes.

Group Type EXPERIMENTAL

rocking bed group

Intervention Type BEHAVIORAL

Babies assigned to the intervention group first will be placed on a rocking bed after routine care such as feeding and diaper changes and when the newborn is stable. A rocking attempt will be applied to the baby placed in the rocking bed for 30 minutes. After 30 minutes, the baby will not be lifted from the bed and will lie in bed for 90 minutes. After a period of two hours in total, the babies will be cared for and fed. Then, babies will be quota and control group measurements will be made.

Control Group

Newborns in the control group will be followed in a fixed bed (open bed or incubator).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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rocking bed group

Babies assigned to the intervention group first will be placed on a rocking bed after routine care such as feeding and diaper changes and when the newborn is stable. A rocking attempt will be applied to the baby placed in the rocking bed for 30 minutes. After 30 minutes, the baby will not be lifted from the bed and will lie in bed for 90 minutes. After a period of two hours in total, the babies will be cared for and fed. Then, babies will be quota and control group measurements will be made.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Born at 32-37 weeks of postmenstruel age
* Not receiving mechanical ventilation support,
* Not receiving analgesia or sedative drug therapy,
* Congenital anomaly, intraventricular hemorrhage, meningitis, chromosomal anomalies, cyanotic congenital heart diseases, neonatal seizures and preterm infants without a diagnosis of sepsis

Exclusion Criteria

• Infants with diseases that may decrease cerebral oxygenation such as cerebral edema, intraventricular hemorrhage, cerebral hypoxia will be excluded from the study.

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes