To determine the effectiveness of parent to parent support on the grief of mothers following premature birth
Design
Quasi-experimental clinical trial with control and intervention group, Convenient sampling with pretest and post test will be done. Sample size with counting of 10% failure will be 90 person that divided in two groups, 45 person in control group and 45 in intervention group. To avoid date contamination, at first control group will be given and after the exit of all control members from setting, intervention group and peer support program will be done.
Settings and conduct
Study will be in NICU of selected hospital of Tehran University of Medical Science. At first, control group will be sampled and after the discharge of all control members, intervention sampling will be started. Designing blindness in sampling isn't possible and mothers who are eligible will enter to project by convenient sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18;
Having premature neonate between 24 to 37 weeks, admitted in NICU;
Having mental health;
No history of divorce or separation from husband;
Mothers of neonates with no life threatening or congenital anomalies;
Being familiar to cell phones an communicating apps;
Exclusion criteria:
Mothers of dying neonates;
Having no consent for participation.
Intervention groups
support program and empathizing with mothers having neonates admitted in NICU will present during 3 periods of time within 2 weeks. Questionnaire will fill before and after intervention. In control group, only questionnaires will be filled two times, after first visit and after two weeks.
Main outcome variables
Motherhood role and breast feeding improvement, Improvement of mother and newborn interactions, Secure attachment in neonate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039464N2
Registration date:2018-11-22, 1397/09/01
Registration timing:registered_while_recruiting
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Marzieh Hasanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4413
Email address
m-hasanpour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Parent-to-Parent Support Program on the Grief of Mothers Following a Premature Birth
Public title
The Effectiveness of Parent-to-Parent Support Program on the Grief of Mothers Following a Premature Birth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
-Age over 18
-having premature neonate between 24 to 37weeks, admitted in NICU
-Having mental health
- No history of divorce or separation from husband
-Neonates of these mothers haven't had life threatening condition or congenital anomalies
-Being familiar to cell phones and communicating apps
Exclusion criteria:
- Mothers of dying neonates
- Having no consent for participation
Age
From 18 years old
Gender
Female
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of
Street address
School of Nursing and Midwifery of Tehran, Tohied Sq. Dr Mirkhani St(East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.TUMS.FNM.REC.1397.035
Health conditions studied
1
Description of health condition studied
Grief of premature birth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Grief of premature birth
Timepoint
First measurement will be from the first visit of mother with her newborn untill 3 days. Second measurement will be after two weeks.
Method of measurement
Researcher made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mothers of neonate who are admitted in NICU will filled questionnaire before and after intervention. At first, peer group will be selected and trained. Then intervention applied in three times. After first visit of mother with her newborn till 3 days, 7 to 10 day after support will be followed by peer and third support plan will be between 10 to 14 days.
Category
Behavior
2
Description
Control group: Mothers in control group will be given routine care and will fill grief questionnaire after the first visit and after 2 weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Valieasr Hospital, Imam Khomeini Hospital Complex
Full name of responsible person
Dr. Khosro Sadeqniat
Street address
Imam Khomeini Hospital Complex., Dr. Qarib Ave., End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2358
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vida Kardan Moghadam
Street address
School of Nursing and Midwifery of Tehran, Tohied Sq. Dr Mirkhani St(East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Tohied Sq. Dr Mirkhani St(East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Tohied Sq. Dr Mirkhani St(East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Tohied Sq. Dr Mirkhani St(East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Title and more details about the data/document
All of data will be reported except the name of participants
When the data will become available and for how long
6 months after printing of results
To whom data/document is available
researchers working in university setting
Under which criteria data/document could be used
researchers working in university setting
From where data/document is obtainable
Dr. Marzieh Hasanpour
m-hasanpour@sina.tums.ac.ir
What processes are involved for a request to access data/document