The effect of massage on compliance to parental role of mothers of premature infants hospitalized in NICU
Design
This is a quasi-experimental study with a control group with parallel groups. the sequential method will be used with non-random Allocation to groups. The sample size is 90 mothers who will be divided equally into two groups.
Settings and conduct
This study will be done in the neonatal intensive care unit of Amol city. The researcher will teach infant massage to the mothers of intervention group in two sessions . Mothers will done massage their child daily for 15 minutes for 5 consecutive days. The mothers of both groups will be completed questionnaire before, in the fifth and 14 days after completing the intervention for massage group.
Participants/Inclusion and exclusion criteria
Inclusion criteria for mothers of preterm infants (32-37 weeks gestation): no history of physical and mental illness and history of infertility. Inclusion criteria for preterm infants: clinical condition stability of baby's and no respiratory distress or congenital abnormalities.
Intervention groups
The infants in the intervention group will be massaged by the mother from the third day of hospitalization for 5 consecutive days. Compliance with Mather's role before the intervention will be re-measured on the fifth and 14th days. At the same time, mothers in the control group also responded to Compliance with Mather's role questionnaire, but only routine care would be provided for them.
Main outcome variables
Compliance with motherhood role
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N11
Registration date:2020-02-27, 1398/12/08
Registration timing:registered_while_recruiting
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage on compliance with maternal role in mothers with premature infants admitted to the intensive care unit
Public title
The effect of massage on compliance with maternal role in mothers with premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 32 to 37 weeks
Stability of the baby's clinical condition and lack of respiratory distress or congenital abnormalities
Having no history of infertility
Exclusion criteria:
Mother's addiction
Maternal history of physical and mental illness
Age
From 1 day old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics Committee of Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Rashid Yasimi St., Vali-e-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.IUMS.REC.1397.700
Health conditions studied
1
Description of health condition studied
compliance with maternal role
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
compliance with maternal roles
Timepoint
The day before the intervention, the fifth day of the intervention and the 14th day after the intervention
Method of measurement
Compliance to maternal role
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage will be performed by the mother from the third day of hospitalization, if the baby is stable, once a daily for 15 minutes for 5 consecutive days. questionnaire will be completed by the mothers before the beginning of the intervention and on the 5th and 14th day after the intervention. .
Category
Behavior
2
Description
Control group: Neonates in this group will receive routine care in the ward and questionnaire will be completed by this mothers in first day, fifth day and 14 days after .
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Mahnaz Shoghi
Street address
Noor Road to Chamestan
City
Amol
Province
Mazandaran
Postal code
47646-76893
Phone
+98 11 4426 4978
Email
shoghi.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Masoud Naseri
Street address
University of Nursing and Midwifery, Shahid yasemi, Kordestan highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
pr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid yasemi. Kodestan highway
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 6543 1000
Email
shoghi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid yasemi. Kodestan highway
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 6543 1000
Email
shoghi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Vali-e-Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
199673883
Phone
+98 21 6543 1000
Email
shoghi.m@iums.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data is encoded to make the profile of individuals unrecognizable and confidential
When the data will become available and for how long
From the end of sampling 1398 to 6 months after the article was published
To whom data/document is available
University Ethics Committee, Project Review Committee, Paper Review Committee, other researchers
Under which criteria data/document could be used
Perform systematic or meta-analysis tasks with a document
From where data/document is obtainable
Mahnaz shoghi
shoghi@iums.ac.ir
What processes are involved for a request to access data/document
The request will be sent by academic email, and information files will be made available to people no later than one week.