1- To compare the effect of massage and prone position on HR & SaO2 changes in preterm infants.
Design
The subjects were selected through convenient sampling and the sample size was calculated by sample size formula as 21 subjects in 3 group. With regard to possible subjects’ drop , 25 subjects were assigned to each group. Group 1 is position, 2 is massage and 3 is control. Then, the neonates meeting the inclusion criteria were assigned to each group (total of three groups) through random computation. In position group, infants will lay in pron position for 1 hour and then will monitor. In massage group, they will massaged based on Field massage protocol and then will monitor for 1 hour. In control group, infants will monitor without any intervention for 1 hour. The HR and SpO2 will record every 15 min.
Settings and conduct
This is an interventional cross- sectional double blind study conducted on all neonates who are hospitalized in NICUs of selected hospitals affiliated to Alborz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Complete infant's vigilance; upper 34 wk; >1500- gr; ability of breastfeeding; RDS diagnosis; O2 dependency; need for hospitalization more than 1 week; SaO2 > 89%.
Exclusion criteria: touch contraindication; derm complications; Paralysis of the limb; major congenital anomalies; asphyxia and addiction of mother; CHD; active bleeding & depended respiratory distress.
Intervention groups
Position group: Subject will be lay on prone position for 1 hour and during this time, the HR and SaO2 variation, will record every 15 min.
Massage group: After receiving massage according Tiffany Field technique, the HR and SaO2 variation, will record every 15 min, during 1 hour monitoring.
Control group: Subject will monitoring for 1 hour without any intervention and during this time, the HR and SaO2 variation, will record every 15 min.
Main outcome variables
Changes of HR and SaO2 in hospitalized neonates in NICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130202012346N2
Registration date:2018-01-05, 1396/10/15
Registration timing:retrospective
Last update:2018-01-05, 1396/10/15
Update count:0
Registration date
2018-01-05, 1396/10/15
Registrant information
Name
Azamolmolouk Elsagh
Name of organization / entity
Isfahan University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2964
Email address
a_elsagh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Science
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-10-12, 1396/07/20
Trial completion date
empty
Scientific title
Comparison of the effect of massage and prone positioning on changes of HR & SaO2 among hospitalized preterm neonates in NICUs .
Public title
comparison of the effect of massage and prone positioning on VS variation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete infant's vigilance
> 2500gr
34 - 37 wk
ability of breastfeeding
Hospitalization more than 1 week
RDS diagnosis
O2 dependency
The lower limit of SaO2 = 89%
Haven't any touch contraindication
Exclusion criteria:
<1500 gr
major congenital anomalies
asphyxia
limb Paralysis
>37 wk
addiction of mother
CHD and dependent disease
active bleeding
derm complications
limb Paralysis
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
75
Actual sample size reached:
75
More than 1 sample in each individual
Actual sample size in each individual:
1
every intervention is individualized for a neonate
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were selected through convenient sampling by drawing without replacement. With regard to 75 possible subjects’ drop , 25 subjects were assigned to each group. It was listed the number and name of the group, on each drop( Position group:1, Massage group:2, control group:3). For each infant, a sheet is drawn randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
All stages of intervention will record by a Panasonic handy cam. Then, recorded films would observed and scored by a person who will blind to assignment of neonates to three different groups. To prevent bias and prejudice, this person will unaware of the group, which the neonate she will watching belonged to, so that scoring was made based on codes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of medical Science
Street address
Faculty of nursing & midwifery. First Golestan- North Esteraki- Baghestan Blvd
City
Karaj
Province
Alborz
Postal code
3146883811
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
Abzums.Rec.1396.47
Health conditions studied
1
Description of health condition studied
prone position
ICD-10 code
ICD-10 code description
2
Description of health condition studied
massage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
HR
Timepoint
1min- 15th min- 30th min- 45th min- 60th min
Method of measurement
Palse Oximetery
2
Description
SaO2
Timepoint
1min-15th min- 30th min- 45th min- 60th min
Method of measurement
palse Oximetery
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group : Position group: Subjects will be laid on prone position for 1 hour, then during this time, the HR and SaO2 variation, will be recorded every 15 min. This intervention will be done for 5 consecutive days in a specific hour for every infant.
Category
Other
2
Description
Intervention group 2nd: Massage group: After receiving massage according to Tiffany Field technique, the HR and SaO2 variation, will be recorded every 15 min, during 1 hour monitoring. This intervention will be done for 5 consecutive days in a specific hour for every infant.
Category
Other
3
Description
Control group: Subject will be monitored for 5 consecutive days in a specific hour, during 1 hour without any intervention and the HR and SaO2 variation, will be recorded every 15 min.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Ali Hospital
Full name of responsible person
Haleh Hatam Gooya
Street address
Se Rah Azimiye- Hazrat Ali Hospital
City
Karaj
Province
Alborz
Postal code
3444111111
Phone
+98 26 3433 6008
Fax
+98 26 3430 4433
Email
hhgooya@gmail.com
2
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Azamolmolouk Elsagh
Street address
Faculty of nursing and midwifert
City
Karaj
Province
Alborz
Postal code
3433331111
Phone
+98 26 3433 6008
Fax
+98 26 3430 4433
Email
a_elsagh@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz university of Medical science
Full name of responsible person
Dr Mohammad Nuri Sepehr
Street address
Alborz university of Medical scienc- Koohnavard st- Taleghani squer- Azimiye
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3255 8920
Email
a_elsagh@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz university of Medical science
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
Alborz University of Medical Science
Full name of responsible person
Azamolmolouk Elsagh
Position
M.S.N Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faulty of Nursing and Midwifery- First Golestan- South Eshteraki- Baghestan Blvd
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6008
Fax
+98 26 3430 4433
Email
a_elsagh@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
Razieh Lotfi
Position
Faculty of Nursing and Midwifery supervisor- Midwifery Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faulty of nursing and Midwifery- First Golestan- South Eshteraki- Baghestan Bolvared
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3443 3324
Fax
Email
razieh_lotfi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
azamolmolouk Elsagh
Position
M.S.N Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faulty of Nursing and Midwifery- First Golestan- South Eshteraki- Baghestan Boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6008
Fax
Email
a_elsagh@nm.mui.ac.ir
Web page address
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
No - There is not a plan to make this available
Title and more details about the data/document
Demographic information of cases include of: age, sex & weight of neonates will report in tables.
When the data will become available and for how long
6 month after publish of results.
To whom data/document is available
Staff nurses and Master of sciences that are involve with neonates.
Under which criteria data/document could be used
E-Mail request. Following the approval of the university law will apply.
From where data/document is obtainable
Deputy of Research of University
What processes are involved for a request to access data/document
Requesting to Deputy of Research of University and doing administrative process