The Effect of Rocking Bed on Preterm Newborns

The Effect of Rocking Bed on Comfort, Physiological Parameters and Cerebral Oxygenation Level of Preterm Infants: a Near Infrared Spectroscopy Study

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

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Nurse's Role; Preterm
• Intervention / Treatment: Behavioral: rocking bed group

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42100
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control Group; Newborns in the control group will be followed in a fixed bed (open bed or incubator).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Information Form	In the form prepared by the researchers in line with the literature in order to collect introductory information about the baby; There are questions for the baby such as gender, mode of delivery, weight at birth, Apgar score (1st and 5th value), gestational age at birth, postnatal age, weight in the study, diet, type of food, frequency of vomiting (O'Reilly et al., 2011; Provasi et al., 2021; Zimmerman & Barlow, 2012). For the final version of the form, opinions were received from 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing.	First measurement- At 15 minutes after admission in the study
COMFORT Scale	The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).	First measurement: T0: just before the intervention
Newborn Follow-up Form	This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.	First measurement: T0: just before the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COMFORT Scale	The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).	Second measurement: T1: 15th minute of the intervention
Newborn Follow-up Form	This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.	Second measurement: T1: 15th minute of the intervention
COMFORT Scale	The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).	Third measurement: T2: 30th minute of the intervention
Newborn Follow-up Form	This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.	Third measurement: T2: 30th minute of the intervention
COMFORT Scale	The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Başbakal, & Yalaz, 2014).	Fourth measurement: T3: 15 minutes after the end of the intervention
Newborn Follow-up Form	This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic.	Fourth measurement: T3: 15 minutes after the end of the intervention

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Director: sibel küçükoğlu, Prof, Selcuk University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: SelcukUnı42Konya

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No