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The Effect of Rocking Bed on Preterm Newborns

Primary Purpose

Preterm, Preterm Birth, Nurse's Role

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rocking bed group
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group: rocking bed group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

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).
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.
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).
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.
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).
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.

Full Information

First Posted
July 20, 2023
Last Updated
August 4, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05978674
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Preterm Birth, Nurse's Role

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: rocking bed group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Newborns in the control group will be followed in a fixed bed (open bed or incubator).
Intervention Type
Behavioral
Intervention Name(s)
rocking bed group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Information Form
Description
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.
Time Frame
First measurement- At 15 minutes after admission in the study
Title
COMFORT Scale
Description
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).
Time Frame
First measurement: T0: just before the intervention
Title
Newborn Follow-up Form
Description
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.
Time Frame
First measurement: T0: just before the intervention
Secondary Outcome Measure Information:
Title
COMFORT Scale
Description
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).
Time Frame
Second measurement: T1: 15th minute of the intervention
Title
Newborn Follow-up Form
Description
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.
Time Frame
Second measurement: T1: 15th minute of the intervention
Title
COMFORT Scale
Description
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).
Time Frame
Third measurement: T2: 30th minute of the intervention
Title
Newborn Follow-up Form
Description
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.
Time Frame
Third measurement: T2: 30th minute of the intervention
Title
COMFORT Scale
Description
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).
Time Frame
Fourth measurement: T3: 15 minutes after the end of the intervention
Title
Newborn Follow-up Form
Description
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.
Time Frame
Fourth measurement: T3: 15 minutes after the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Küçükoğlu, Prof
Organizational Affiliation
Selcuk University
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1545324
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.
Results Reference
background
PubMed Identifier
27777223
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.
Results Reference
background
PubMed Identifier
21474003
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.
Results Reference
background
PubMed Identifier
34438551
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.
Results Reference
background
PubMed Identifier
19692803
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.
Results Reference
background
PubMed Identifier
22157627
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.
Results Reference
background

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The Effect of Rocking Bed on Preterm Newborns

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