Comparison of the effect of massage therapy with and without oil on weight gain and triglyceride levels in premature
Design
Double blind, parallel group randomized-controlled clinical trial with 94 cases are divided into 2 intervention groups, massage therapy with oil (33 cases), massage therapy without oil (30 cases) and control group (30 cases).
Settings and conduct
In this double blind, randomized-controlled clinical trial , which is done to evaluate the effect of massage therapy with and without oil on weight gain and triglyceride levels of 94 preterm infants admitted to the neonatal intensive care unit at Shohada Tajrish and Mahdieh Hospital, Tehran, Iran, according to the inclusion and exclusion criteria, are divided into three groups. After filling the permission form with parents, care giver divides the neonates according to the random numbers and random numbers generator software into three groups and parents are not aware of the type of intervention.The massage therapists were informed about groups’ division, while the nurse who measured the daily weight and serum triglyceride samples, the researcher who recorded the information, and the statistician who analyzed the data were blind to grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonates with gestational age less than 37 weeks. Hemodynamically stable condition and without serious medical illness and receiving at least 60 kcal per day orally.
Exclusion criteria: Hemodinamically unstable
Intervention groups
The first intervention group: oil massage therapy. Second intervention group: massage therapy without oil. Control group: routine neonatal care without any intervention.
Main outcome variables
Weigh; Serum triglyceride level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040036N3
Registration date:2022-07-12, 1401/04/21
Registration timing:retrospective
Last update:2022-07-12, 1401/04/21
Update count:0
Registration date
2022-07-12, 1401/04/21
Registrant information
Name
Narges Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4442 7956
Email address
nargesgholami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
2019-09-01, 1398/06/10
Actual recruitment end date
2021-04-30, 1400/02/10
Trial completion date
2021-04-30, 1400/02/10
Scientific title
The effect of massage therapy with and without oil on weight gain and triglyceride levels of premature
Public title
Massage therapy in premature weigh gain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 37 weeks
At least 60 kcal / kg intake daily orally
Not having any serious medical condition
Exclusion criteria:
Hemodynamically unstable
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
94
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
First, a framework was made of numbers 1-94 , then the assignment of these numbers to group 1-3 was determined based on the random numbers table. A computer software program (www.random.org) was used to produce random numbers to allocate neonate to 3 groups and were be placed in an envelope and marked with neonate number and group code (massage therapy with oil, massage therapy without oil and control).
Blinding (investigator's opinion)
Double blinded
Blinding description
After filling the permission form with parents, care giver divides the neonates according to the random numbers and random numbers generator software into three groups and parents are not aware of the type of intervention.The massage therapists were informed about groups’ division, while the nurse who measured the daily weight and serum triglyceride samples, the researcher who recorded the information, and the
statistician who analyzed the data were blind to grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
Kodakyar st , Shahriary Sq , Chamran High way
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398. 550
Health conditions studied
1
Description of health condition studied
Premature weight and serum triglyceride level
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
weight
Timepoint
Before the intervention and five-day period of study
Method of measurement
Rossmax WE300 baby digital scale
Secondary outcomes
1
Description
Serum triglyceride level
Timepoint
Before intervention and fifth day of study
Method of measurement
mg per decilitre ( Automated Analyzer, Mindray BS-200 analyzer)
Intervention groups
1
Description
First intervention group: massage therapy with oil. The massage therapist performed 15-minute massage with coconut oil daily for 5 days at 9 AM and 13 PM o'clock.
Category
Treatment - Other
2
Description
Second intervention group: massage therapy without oil. The massage therapist performed 15-minute massage with tepid water daily for 5 days at 9 AM and 13 PM o'clock.
Category
Treatment - Other
3
Description
Control group: Routine neonatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish and Mahdieh Hospital
Full name of responsible person
Ali Naseh
Street address
Qods Sq, Tajrish street
City
Tehran
Province
Tehran
Postal code
989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Gholami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
704 B,Jam e Jam tower,Heidari Moghadam st,south Sardar jangal,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 4442 7956
Fax
Email
nargesgholami724@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Gholami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Loghman hospital,Kargar st
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5182
Email
nargesgholami@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Gholami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Loghman hospital,Kargar st
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5182
Email
nargesgholami@sbmu.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Final data has been given to Vice-Chancellor of Research Affairs of Shahid Beheshti University of Medical Sciences
When the data will become available and for how long
2022-2031
To whom data/document is available
pediatricians
Under which criteria data/document could be used
All researchers are allowed to receive data details and protocols according professional ethics.
From where data/document is obtainable
Contact with authors
What processes are involved for a request to access data/document
By email to author(nargesgholami@sbmu.ac.ir). It takes about 7 days.