1. Home
  2. Approved trials
  3. » فارسی

En Assessment of Effectiveness Of Clustering Care on Sleep Behaviors of Premature Neonates Hospitalized in Neonatal Intensive Care Unit

Protocol summary

Study aim
Determining and comparing the mean score of neonatal sleep in the control group before and after routine interventions 2- Determination and comparison of the average score of neonatal sleep in the intervention group before and after the cluster care 3. Comparison of the mean score of neonatal sleep in the control and intervention groups
Design
The population of this study is all preterm infants admitted to Arash Hospital. The number of samples is 30, 15 of whom will be the control group of 15 in the intervention group. Selection of samples will be available and each participant will be given a specific one.
Settings and conduct
The researcher explores the case studies only in a research entitled The Effect of Clustering on the Sleep Behavior of Premature Babies in a Shift in the Morning and by a Nursing Constant in the Neonatal Intensive Care Unit of Arash Hospital.The beginning of the study will be from the beginning of the shift to the end of the shift. In the morning shift from 7 to 13, a newborn in the control group. Conventional care for the newborn in the intervention group. Cluster care (including all non-invasive measures such as feeding, changing position, weighing, changing props, size Getting round the head, giving medications ... and taking one of the aggressive actions such as replacing the veins, taking blood or suckling the baby). Immediately after feeding, based on the evolutionary behaviors of the infant (such as limb movement, facial swelling, crying ...), for 45 minutes, the baby's sleep behaviors are observed by the researcher or by the trained researcher. Will take. In each shift, two sleep cycles will be monitored and behaviors will be recorded every two minutes by the utility tool.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: fetal age from 30 to 37 weeks, minimum weight of 1000 grams, absence of abnormalities in the body, absence of prohibition of position change, having a seizure order and conditions for withdrawal from septicemia and intolerance in each of the stages of the study
Intervention groups
Control group: After receiving consent from the parents, the baby received the usual care of the department. During the whole shift of the morning, two infant sleep cycles each one was observed and recorded for 45 minutes of sleep behaviors of the newborns in the relevant questionnaireCroup Intervention: After receiving parental consent, the baby is receiving clustering and categorized care. During a full shift in the morning, two infant sleep cycles each observed and examined for 45 minutes of neonatal sleep behaviors.The registration is placed in the relevant questionnaire. There is no intervention on the baby throughout the study period.
Main outcome variables
Improvement of sleep in newborns results in more weight gain, shorter hospitalization time, and improved arterial oxygen levels.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171021036909N1
Registration date: 2017-12-25, 1396/10/04
Registration timing: registered_while_recruiting

Last update: 2017-12-25, 1396/10/04
Update count: 0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
batool pouraboli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4413
Email address
b-pouraboli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-18, 1396/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
En Assessment of Effectiveness Of Clustering Care on Sleep Behaviors of Premature Neonates Hospitalized in Neonatal Intensive Care Unit
Public title
En Assessment of Effectiveness Of Clustering Care on Sleep Behaviors of Premature Neonates Hospitalized in Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
En Inclusion criteria: gestational age of 30-37 week At least 1000 grams weight Not having abnormalities at birth Not having a position change Having the command of gavage No use of sedative in the last 24 hours Not having seizures and taking anticonvulsants Dont consumption opiod by mother during pregnancy
Exclusion criteria:
Exclusion criteria:Toxic septicemia Intra ventricular hemorrhage grade III and IV Intolerance at each stage of the study
Age
From 210 days old to 259 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
College Nursing and Midwife Street West Nosrat Squre Tohid
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3590

Health conditions studied

1

Description of health condition studied
Preterm Infants’ Sleep
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified

Primary outcomes

1

Description
Neonate Sleep Behaviors
Timepoint
After feeding
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Physiological signs of the neonate
Timepoint
During the study period
Method of measurement
Prchatl questionnaire

Intervention groups

1

Description
In the control group, after getting permission from parent and general care, the sleep behaviors of neonates will be record by Perchtl after nutrition every 2 minute for 45 minute. Two cycle of sleep will be evaluated in every shift.
Category
Rehabilitation

2

Description
On the other hand, in the intervention group, the care will be done as clustered manner after getting permission from parent. Clustered care means doing several nursing care (including: changing position, changing probe location, giving medicine, weight,
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Marjan Bazrgari
Street address
Corner 126 Kalantary, Shahid Baghbaniyan Ave., Resalat Highway
City
Tehran
Province
Tehran
Postal code
1686947415
Phone
+98 21 7788 3283
Email
ma.bazrgari@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Taghizade
Street address
College Nursing and Midwife Street West Nosrat Squre Tohid
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 7729 3103
Email
ma.bszrgari@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Bazrgari
Position
Graduate Student in NICU Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat Eastern Street, Tohid Square.
City
Tehran
Province
Tehran
Postal code
1686947411
Phone
+98 21 7729 3103
Fax
Email
ma.bazrgari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Batoul Pouraboli
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Nosrat Eastern Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Fax
Email
b-pouraboli@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Bazrgari
Position
Master student of Neonatal Care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 3.No.6. Daneshvar St., No. 196 Boulevard, 3rt Sq. Tehranpars
City
Tehran
Province
Tehran
Postal code
1686947411
Phone
+98 21 7729 3103
Fax
Email
ma.bazrgari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...