Protocol summary

Summary
Objective main:The impact of empowering mothers of infants hospitalized in neonatal intensive care unit on their participation rate in the infant care. Design: The study is single group, Semi- experimental method, with a comparison before and after event. Setting and conduct: Training needs of mothers are determined by questionnaire of training needs. The training plan is conducted based on measuring the training needs of mothers. Checklist of mother participation before and after the intervention is completed, then after checklist completion, educational intervention is implemented at time interval of 2 to 4 days. The participation rate of mothers is determined before and after the educational program. Participants including major eligibility criteria: Inclusion criterion for this study is to have the age above of 15 and the ability to read and write. Exclusion criteria according to information obtained from medical files and mother is the mother with a mental and physical disease, and then the infants with an illness incompatible with life. 59 mothers having hospitalized infant in mofid medical center are participated in this study. Interventions: The intervention of the study is educational plan including giving mothers the booklets and holding training sessions for them. The main outcome variables: Determining the educational needs of mothers regarding to newborn care in neonatal intensive care unit to implement empowerment programs. Determining mother participation rate regarding to newborn care before and after implementing the empowerment program. Comparing mother participation rate regarding to newborn care unit before and after implementing the empowerment program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112631099N1
Registration date: 2017-01-20, 1395/11/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Manijeh Shakibifard
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health,Care Services, Nersing and Midwifery Colla
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
manijehshakibi49@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences and Health Care Services, Nursing and Midwifery Collage of Vice chancellor of Reaserch
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Empowering Mothers of Infants hospitalized in Neonatal Intensive Care Unit on Their Participation Rate in the Infant Care.
Public title
The Impacts of Mothers Epowerment on Thier Participation in Newborn Care
Purpose
Supportive
Inclusion/Exclusion criteria
Major inclusion criterion for this study is to have the age above 15 and the ability to read and write for mother. Major exclusion criteria is the mother with a mental and physical disease, and then the infants with an illness incompatible with life.
Age
From 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 59
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences and Health Care Services, Nersing and Midwifery Colla
Street address
Nersing and Midwifery Collage Opposite of Shahid Rajaee Hospital, Niayesh Cross Road, Vaiye Asr Ave, Tehran
City
Tehran
Postal code
1985717443
Approval date
2016-05-16, 1395/02/27
Ethics committee reference number
IR.SBMU.PHNM.1395.387

Health conditions studied

1

Description of health condition studied
Empowerment
ICD-10 code
F60.7
ICD-10 code description
Dependent personality disorder

Primary outcomes

1

Description
Determining mother participation rate regarding to newborn care before and after implementing the empowerment program.
Timepoint
Participation rate of mothers is determined before the educational intervention and 2 to 4 days after the intervention.
Method of measurement
Chek list of Mothers Participation

Secondary outcomes

empty

Intervention groups

1

Description
In this study implementing the training program is an intervention. First the educational needs of mothers were obtained by questionnaire, and accordingly educational programs are implemented. Booklet and face to face training were instruction methods. The participation of mothers is determined and compared before and after implementing the training program lasting 2 to 4 days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kodakan Mofid Hospital
Full name of responsible person
Maryam Momeni Oremi, BS., Nursing Maneger
Street address
Before Mirdamad, Shariati Street,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti Univercity of Medical Sciences and Health Care Services, Nursing and Midwifery Colla
Full name of responsible person
Dr.Mahrokh Dolatian
Street address
Nursing and Midwifery Collage, Opposite of Shahid Rajaee Hospital, Niayesh Cross Road, Valiye Asr Ave,Tehran
City
Thran
Grant name
Grant code / Reference number
7536
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Univercity of Medical Sciences and Health Care Services, Nursing and Midwifery Colla
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti Univercity of Medical Sciences and Health Care Services, Nursing and Midwifery Colla
Full name of responsible person
Dr. Lida Nikfarid
Position
Nursing PHD, Comaster
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Opposite of Shahid Rajaee Hospital, Niayesh Cross Road, Valiye Asr Ave,Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
InInIn2000@yahoo.com ; sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Univercity of Medical Sciences and Health Care Services, Nursing and Midwifery Colla
Full name of responsible person
Dr. Fatemeh Alaee korahrodi
Position
Nursing PHD, Comaster
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Opposite of Shahid Rajaee Heart Hospital, Niayesh Cross Road, Valiye Asr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
+98 21 8820 2521
Email
fatemeha71@gmail.com ; sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health,Care Services, Nersing and Midwifery Colla
Full name of responsible person
Manijeh Shakibifard
Position
Master Degree Student of Neonatal Intensive Care Unit, Nurse
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Opposite of Shahid Rajaee Hospital, Niayesh Cross Road, Valiye Asr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5372
Fax
+98 21 8820 2521
Email
manijehshakibi49@gmail.com ; sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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