The effect of olive oil massage on increasing the weight gain of newborns
Design
A clinical trial with a control group, with parallel groups, randomized on 120 pre-mature babies. The rand function of Excel software was used for randomization.
Settings and conduct
Preterm babies admitted to the NICU department of Bo Ali Hospital in Ardabil are treated with abdominal massage and abdominal massage with olive oil. The first group only received abdominal massage, the second group received abdominal massage with olive oil, and the third group did not receive any type of massage.
Participants/Inclusion and exclusion criteria
Premature babies without respiratory distress and underlying disease can enter the study.Premature babies less than 34 weeks are included in the study.
Intervention groups
Massage with olive oil, Massage from the head to the tip of the baby's feet while the baby's body is uncovered, even though he only has a diaper, will be done three times a day for 15 minutes. The type of olive oil will be virgin olive oil and the product of a manufacturing company.
Main outcome variables
Weight on day 7
Weight on day 10
Weight on day 14
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240317061319N1
Registration date:2024-04-21, 1403/02/02
Registration timing:prospective
Last update:2024-04-21, 1403/02/02
Update count:0
Registration date
2024-04-21, 1403/02/02
Registrant information
Name
mina sarreshtedaraslahe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 4549
Email address
minasareshtedar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-24, 1403/02/05
Expected recruitment end date
2024-05-06, 1403/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olive oil massage on weight gain in preterm infants
Public title
Investigating the effect of massage on weight gain of preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants
Exclusion criteria:
Respiratory distress
Underlying disease
Age
From 7 days old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done using random allocation software.
Sequential sampling for the entry of premature babies into the study is done on the 7th day of the baby's life. Study participants who meet the eligibility criteria will be selected on the basis of convenience. The first participant in the study will be in the control group and then with similar characteristics in the intervention group, this work will continue until the desired sample size is reached.
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
Ethics Committee of Ardabil University of Medical Sciences
Street address
Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2024-02-19, 1402/11/30
Ethics committee reference number
IR.ARUMS.REC.1402.372
Health conditions studied
1
Description of health condition studied
Prematurity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Baby's weight
Timepoint
The effect of olive oil massage on baby's weight on days 7, 10, 14
Method of measurement
Using a digital scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Babies massaged with olive oil
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Mina sarreshtedar
Street address
No.7, Street 7, Azerbaijan bostan ., Azadi Town
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۵۷۷۶۸۹۵
Phone
+98 45 3372 4549
Email
minasareshtedar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Babak golami
Street address
Daneshgah Ave
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۵۷۷۶۸۹۵
Phone
+98 45 3372 4549
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Mina Sarreshtedar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.7 , Street 7 .,Azarbayjan Bostan ., Azadi Town
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۵۷۷۶۸۹۵
Phone
+98 45 3372 4549
Email
minasareshtedar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mina Sarreshtedar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.7 ,Street 7., Azarbayjan Bostan.,Azadi Town
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۵۷۷۶۸۹۵
Phone
+98 45 3372 4549
Email
minasareshtedar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mina sarreshtedar
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.7 , Street 7 .,Azarbayjan Bostan ., Azadi Town
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۵۷۷۶۸۹۵
Phone
+98 45 3372 4549
Email
minasareshtedar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available