Clinical trial NCT05978674: The Effect of Rocking Bed on Preterm Newborns
Official title: The Effect of Rocking Bed on Comfort, Physiological Parameters and Cerebral Oxygenation Level of Preterm Infants: a Near Infrared Spectroscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Preterm Birth
Nurse's Role
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 36
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Information Form
timeFrame: First measurement- At 15 minutes after admission in the study
measure: COMFORT Scale
timeFrame: First measurement: T0: just before the intervention
measure: Newborn Follow-up Form
timeFrame: First measurement: T0: just before the intervention
Secondary outcomes:
measure: COMFORT Scale
timeFrame: Second measurement: T1: 15th minute of the intervention
measure: Newborn Follow-up Form
timeFrame: Second measurement: T1: 15th minute of the intervention
measure: COMFORT Scale
timeFrame: Third measurement: T2: 30th minute of the intervention
measure: Newborn Follow-up Form
timeFrame: Third measurement: T2: 30th minute of the intervention
measure: COMFORT Scale
timeFrame: Fourth measurement: T3: 15 minutes after the end of the intervention
measure: Newborn Follow-up Form
timeFrame: Fourth measurement: T3: 15 minutes after the end of the intervention
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Sibel Küçükoğlu, Prof
role: STUDY_DIRECTOR
References:
citation: Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.
citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
citation: O'Reilly R, Grindle C, Zwicky EF, Morlet T. Development of the vestibular system and balance function: differential diagnosis in the pediatric population. Otolaryngol Clin North Am. 2011 Apr;44(2):251-71, vii. doi: 10.1016/j.otc.2011.01.001.
citation: Provasi J, Blanc L, Carchon I. The Importance of Rhythmic Stimulation for Preterm Infants in the NICU. Children (Basel). 2021 Jul 29;8(8):660. doi: 10.3390/children8080660.
citation: van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
citation: Zimmerman E, Barlow SM. The effects of vestibular stimulation rate and magnitude of acceleration on central pattern generation for chest wall kinematics in preterm infants. J Perinatol. 2012 Aug;32(8):614-20. doi: 10.1038/jp.2011.177. Epub 2011 Dec 8.