Determining the effect of aromatherapy with rosa damascena essential oil on feeding tolerance and weighing of premature babies hospitalized in neonatal intensive care units
Design
A controlled, parallel-group, unblinded, quasi-randomized, phase 3 clinical trial on 60 preterm infants. Lottery was used for randomization.
Settings and conduct
The method of assigning two groups is a quasi-random clinical trial in the neonatal special care department of Imam Reza Hospital (in the form of a lottery for the first intervention or control group in two separate time periods). Olfactory stimulation in 4 times by the researcher and under the supervision of the corresponding nurse, starting with gavage in the form of a pad impregnated with the essence of the rose flower in the form of three drops on A cotton ball is applied and the gavage is completed.
Participants/Inclusion and exclusion criteria
Premature babies with a gestational age of 28 to 32 weeks
Birth weight below 1500 grams and at least 1000 grams
Breastfeeding
Not having any life-threatening congenital abnormalities
No necrotizing Enterocolitis
No positive blood culture and meningitis
No invasive mechanical ventilation
Intervention groups
Babies in the intervention group are weighed every morning with a specific scale and by the researcher. Gavage with breast milk will be done. The olfactory stimulation is performed at the beginning of gavage in the form of a pad impregnated with the essence of the rose flower in the form of three drops on a cotton ball and ends at the end of the gavage. This intervention continues for one week. Babies of the control group are weighed every morning with a specified scale by the researcher. Gavage with breast milk will be done every two hours according to the routine of the neonatal intensive care unit, and no intervention will be done for this group.
Main outcome variables
Nutritional Tolerance
Weighing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057853N1
Registration date:2023-04-29, 1402/02/09
Registration timing:prospective
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Asieh Bidel baze
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3259 6950
Email address
bidelas2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aromatherapy with Rosa Damascena Essential oil on Nutritional Tolerance and Weighing in Premature Infant in Neonatal Care Unit
Public title
The Effect of Aromatherapy with Rosa Damascena Essential oil on Nutritional Tolerance and Weighing in Premature Infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature babies with a gestational age of 28 to 32 weeks
Birth weight below 1500 grams and at least 1000 grams
Breastfeeding
Exclusion criteria:
Having any life-threatening congenital abnormalities
Necrotizing Enterocolitis
Positive blood culture and meningitis
Invasive mechanical ventilation
Age
From 2 days old to 10 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University of Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.002
Health conditions studied
1
Description of health condition studied
Other feeding problems of newborn
ICD-10 code
p92.8
ICD-10 code description
Other feeding problems of newborn
Primary outcomes
1
Description
Nutritional Tolerance
Timepoint
Daily
Method of measurement
Nutritional Tolerance Check List
2
Description
Weighing
Timepoint
Daily
Method of measurement
Scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infants in the intervention group every morning at 7:00-7:30 with a specific scales. They are weighed by the researcher. gavage with breast milk in 4 times (8 am, 12 noon, 4 pm and 8 pm) by the researcher. It will be done under the supervision of the relevant nurse. Olfactory stimulation will be done every time with the beginning of gavage as a pad soaked in the essential oil of the rose.(prepared under the supervision of a pharmacist) is done as three drops on a cotton ball and at the end of gavage. It arrives This intervention continues for one week
Category
N/A
2
Description
Control group: Babies in the control group are weighed every morning at 7:30-7:30 a.m. with a specified scale by the researcher. Gavage with breast milk. Two hours will be done according to the routine of the neonatal intensive care unit, and no intervention will be done for this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza's Hospital
Full name of responsible person
Behnam Voshani Hamidreza
Street address
Ibn Sina Street, Imam Reza (AS) Hospital Square, Imam Reza (AS) Educational Research and Treatment Center, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
bidelas2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghayor Mobarhan Majid
Street address
Research and Technology Vice-Chancellor, building number one of Mashhad University of Medical Sciences (Qureshi), second floor, in front of University Avn 18, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 7840
Email
sram@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Behnam voshani Hamidreza
Position
Faculty member of the child and infant department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 5, Delavaran Avn 25, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177156156
Phone
+98 51 3259 6950
Email
Behnamhr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Behnam voshani Hamidreza
Position
Faculty member of the child and infant department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 5, Delavaran Avn 25, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177156156
Phone
+98 51 3259 6950
Email
Behnamhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Bidel Baze
Position
Master's student in neonatal intensive care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 79, Alimardani Avn 45, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9158775477
Phone
+98 51 3259 6950
Email
bidelas2@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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