Effectiveness and ineffectiveness of aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of selected training hospitals of Esfahan in 2015
This study will be done with aim to investigate the aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of Investigate the aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of Alzahra hospitals of Esfahan in 2015hospitals of Esfahan in2015. This study is a single blind clinical trial.
60 premature infants 29-33 weeks with 900 to 1500 gr weight that admission in NICU ward are selected by available methods and randomly will placed in two groups of experiment and control with30 people. In the experimental group, in addition to conventional therapy,aromatherapy with damask rose extracts starton the second day of birth from 6Am and by pouring2 drops of damask rose extracts 10% on linen that is located at a distance of 3 cm of infant head. In the control group in addition to conventional therapy, therapy on the second day of birth from 6Am and by pouring2 drops of Distilled water on linen that is located at a distance of 3 cm of infant head and in the two groups at, 9.12, 15, 18, o’clock will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation will bechart and record .
Inclusion criteria: children between 3-29 weeks gestational age; birth weight between 900-1500 grams; The baby's blood hemoglobin level higher than 10g /dl;infants Parental consent; Lack of oxygen uptake through cpAP; no need for infant ventilator; lack of heart disease or any infection.
Exclusion criteria were: discharge or death of an infant before the end of the intervention period; the incidence of respiratory symptoms and skin allergy during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121925601N4
Registration date:2016-01-04, 1394/10/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-04, 1394/10/14
Registrant information
Name
Saeideh Aghagoli
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25366621496
Email address
aqagholi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan university of medical science, research vice chancellor
Expected recruitment start date
2016-01-08, 1394/10/18
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness and ineffectiveness of aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of selected training hospitals of Esfahan in 2015
Public title
Investigate the aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of selected training hospitals of Esfahan in 2015
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infants between 29-33 weeks gestational age; birth weight between 900-1500 grams; The baby's blood hemoglobin level higher than 10g /dl;infants Parental consent; Lack of oxygen uptake through cpAP; no need for infant ventilator; lack of heart disease or any infection.
Exclusion criteria were: discharge or death of an infant before the end of the intervention period; the incidence of respiratory symptoms and skin allergy during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Ethics, Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Postal code
Approval date
2015-08-31, 1394/06/09
Ethics committee reference number
IR.MUI.REC.1394.3.410
Health conditions studied
1
Description of health condition studied
Apnea
ICD-10 code
J98
ICD-10 code description
Other diseases of the respiratory system
Primary outcomes
1
Description
Heart rate
Timepoint
24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours
Method of measurement
By monitoring device
2
Description
Arterial blood oxygen saturation percent
Timepoint
24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours
Method of measurement
By monitoring device
3
Description
The number of episodes of apnea
Timepoint
24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours
Method of measurement
By direct observation
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, in addition to conventional therapy,aromatherapy with damask rose extracts starton the second day of birth from 6Am and by pouring2 drops of damask rose extracts 10% on linen that is located at a distance of 3 cm of infant head then at, 9,12, 15, 18, o’clock will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation will bechart and record .
Category
Treatment - Drugs
2
Description
In the control group in addition to conventional therapy, therapy on the second day of birth from 6Am and by pouring2 drops of Distilled water on linen that is located at a distance of 3 cm of infant head then at, 9.12, 15, 18, o’clock will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation will be chart and record .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Saeideh Aghagoli
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Akram Mazaheri
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Street of Hezarjarib
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hazrate Masomeh Hospital
Full name of responsible person
Saeideh Agha Goli
Position
MSc student of Emergency care of infant
Other areas of specialty/work
Street address
Hazrate Masomeh Hospital, Before terminal, After Shahid Zeinodin Square
City
Ghom
Postal code
Phone
+98 21636665553
Fax
Email
Aghagoli1974@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Ghazavi
Position
MSc of Nursing Training
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Postal code
Phone
+98 31 3792 3060
Fax
Email
ZOHRE_GHAZAVI@NM.MUI.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeideh Agha Goli
Position
MSc student of Emergency care of infant
Other areas of specialty/work
Street address
Hazrate Masomeh Hospital, Before terminal, After Shahid Zeinodin Square
City
Ghom
Postal code
Phone
+98 21636665553
Fax
Email
Aghagoli1974@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)