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The effect of aromatherapy with Rosa damascenes on the sleep state of premature neonates admitted to the neonatal intensive care unit of Ali ebne Abitaleb hospital in Zahedan ,2020

Protocol summary

Study aim
Determining the effect of aromatherapy with Rosa damascenes on the sleep state of premature neonates admitted to the neonatal intensive care unit of Ali ebne Abitaleb hospital in Zahedan ,2020
Design
The clinical trial study is a randomized double-blind.64 samples will be divided into intervention and control groups by alternative block method.The size of all the blocks is equal.
Settings and conduct
Among the neonates admitted to the NICU of Zahedan's Ali Ibn Abi Talib Hospital,which have the criteria for entering the study, sampling is performed by sampling block method in two groups of intervention (The smell of Rosa Damascenes) and control ( Distilled water) will be assigned.The newborn is placed embryoically in the nest inside the double-walled incubator.The newborn sleeps for 20 minutes before, 70 minutes during,20 minutes after placing the pad soaked in Rosa Damascenes, which is 30 cm away from the newborn 's head, at intervals of both.According to the Als's tool,the type of sleep status is determined and recorded in the instrument table. In order to perform the course in this research,sampling and interventions will be performed with the help of the researcher. All interventions will be recorded by the video camera.
Participants/Inclusion and exclusion criteria
Age between 30 and 37 fetal weeks No history of drug abuse in the mother Lack of severe respiratory distress having consent form parents Not having a chest tube and a umbilical catheter Does not use of sedative drugs for the neonate Not having icterus,congenital abnormalities,seizures
Intervention groups
Intervention group(The smell of Rosa Damascenes) control group(Distilled water)
Main outcome variables
Premature infant's sleep:Observing the newborn's behavior using the Als's Sleep and AwakeningTools,which includes 6 deep sleep conditions A.B,light sleep A.B,drowsiness A.B,by the researcher

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171007036599N4
Registration date: 2020-07-25, 1399/05/04
Registration timing: prospective

Last update: 2020-07-25, 1399/05/04
Update count: 0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
freshte ghaljaei
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
ghaljaei-f@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-05, 1399/07/14
Expected recruitment end date
2020-12-18, 1399/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Rosa damascenes on the sleep state of premature neonates admitted to the neonatal intensive care unit of Ali ebne Abitaleb hospital in Zahedan ,2020
Public title
The effect of aromatherapy with Rosa ِdamascenes on the sleep state of premature neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 and 37 fetal weeks Sustainable physiological symptoms Lack of severe respiratory distress No history of drug abuse in the mother Completion of the infant consent form for participation in research by parents
Exclusion criteria:
Having a chest tube and a umbilical catheter Use of narcotic, sedative and anesthetic drugs for the neonate Having diseases: icterus, congenital neurological abnormalities, meningitis, seizures, encephalopathy and interstitial hemorrhage
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The permuted block stratified randomization method will be used. The stratified randomization method allows the elimination of possible heterogeneities between the two groups in terms of age and sex. Also, the block randomization method provides the possibility of creating a balance in the number of samples assigned to each of the study groups. The randomization method is that the participating infants are classified at the beginning of the arrival in terms of age (30-33 and 33-37 weeks) and sex (girl-boy). In the next step, the infants will be assigned individually to group A or B according to the quadruple blocks. Random sequence of quadruple blocks will be selected as ABAB / ABBA / BAAB / BABA / AABB / BBAA from the random number table. The classification and blocking process will continue until the study sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research,sampling and intervention will be done with the help of the researcher. All interventions will be recorded by the video camera . First, the researcher will be placed on the newborn's bed to evaluate and complete the form while examining the infant's sleep status and then the researcher will review the film's information to confirm the accuracy and the final score will be given. Researchers are unaware of the newborn's sleeping position on the newborn's bed , as well as the researcher's help when watching the recorded video of the intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hassabi Square, Janat Blvd, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2019-11-18, 1398/08/27
Ethics committee reference number
IR.ZAUMS.REC.1398.383

Health conditions studied

1

Description of health condition studied
Premature neonate's sleep
ICD-10 code
P07.0
ICD-10 code description
Extremely low birth weight newborn

Primary outcomes

1

Description
Sleep status of preterm neonate
Timepoint
During 20 minutes before the intervention, 70 minutes during intervention and 20 minutes after the intervention
Method of measurement
Observation the behavior of neonate with use of sleep and waking scale of Als, by researcher and helpre

Secondary outcomes

1

Description
Physiological signs of the neonate
Timepoint
Before, during and after the intervention
Method of measurement
Pulse oximetry

Intervention groups

1

Description
Intervention group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in Zahra's organic rose at a distance of 30 cm from the baby's head and is recorded in the table.
Category
Treatment - Drugs

2

Description
Control group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in" Distilled water" at a distance of 30 cm from the baby's head and is recorded in the table.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali al- Ibn Abi Talib Hospital in Zahedan
Full name of responsible person
Fereshteh Ghaljaei
Street address
Dr. Hassabi Square, Janat Blvd, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5572
Fax
+98 54 3329 5572
Email
Ghaljaei-f@zaums.ir
Web page address
http://zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
NoorMohamad Bakhshani
Street address
Dr. Hasabie Square, Persian Gulf Blvd, Pardis Office Complex, Zahedan University of Medical Sciences and Health Services
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan University of Medical Sciences and Health Services
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
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Ghaljaei-f@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Ghaljaie-f@zaums.ac.ir
Web page address
http://zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fereshteh Ghaljaei
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ghaljaie-f@zaums.ac.ir
Web page address
http://zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcomes of the participants are public.
When the data will become available and for how long
The main outcomes of the participants are public.
To whom data/document is available
The researchers in academic and scientific institutions.
Under which criteria data/document could be used
The statistical result.
From where data/document is obtainable
Faculty of Nursing and Midwifery, Zahedan Telephone: 05433442481 Postcode: 9816913396 Address: Mashahir Square, Nursing and Midwifery Faculty, Zahedan
What processes are involved for a request to access data/document
Contact the Nursing Faculty Library section.
Comments
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