Effects of an empowerment program on the mother infant attachment in nulliparous mothers
Design
In this clinical trial study, 80 nulliparous mothers who are eligible to enter the study are selected. The mothers are randomly divided into two groups of control and intervention.
Settings and conduct
This clinical trial will be done in the women ward of Imam Sajjad Hospital and Sohrab Ali Bakhshi Health Center in Shahriar city. An empowerment educational program will be done for the mothers in the experimental group at last month of pregnancy, while the mothers in the control group only received the routine care of during pregnancy. Then, the first day of birth of the neonates in the hospital, using maternal attachment questionnaire to the neonate, observed and recorded the mother's attachment behaviors during lactation and without mother's knowledge within 15 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnancy is monogamous; The age range of the mother is between 16-35 years old; All mothers have normal delivery; The baby is not from IVF or infertility. Exclusion criteria: Pregnancy is Polygons; Mothers aged less than 16 years or more From 35 years of age; Cesarean section delivery; The neonate born to IVF or infertility.
Intervention groups
An educational program will be conducted by a researcher and lecture and a group using a projector video for mothers. The training includes the first session: Primary care education for the newborn, Second session: Training the symptoms of the risk and disease in the newborns, and the third session: Developmental care education.
Main outcome variables
Attachment of nulliparous women to their neonates.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140604017972N8
Registration date:2017-12-25, 1396/10/04
Registration timing:retrospective
Last update:2017-12-25, 1396/10/04
Update count:0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of iran univercity of medical science
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program on mother infant attachment in nulliparous women
Public title
The effect of empowerment program on mother infant attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Pregnancy is monogamous; Pregnancy asked; Not being pregnant (gestational hypertension, gestational diabetes, bleeding, etc.); The mother's lack of medical and mental illness and depression; Being Iranian ; Mother's Not Addicted to Alcohol and Drugs; The baby is not from IVF or infertility; The baby is a family member; mother has no history of abortion and baby death; The age range of the mother is between 16-35 years old; All mothers have normal delivery.
Exclusion criteria:
Exclusion criteria: Pregnancy is Polygons; unwanted pregnancy; mother has to Pregnancy Diseases (gestational hypertension, gestational diabetes, bleeding, etc) ; Maternal affliction to medical and psychological illnesses and depression; non-Iranian mothers; maternal addiction to alcohol and drugs; neonate born to IVF or infertility; mother has a history of abortion and stillbirth; mothers aged less than 16 years or more From 35 years of age; Cesarean section delivery; Severe and prolonged labor and rupture grade 3 and 4 Perinal; Neonate disease and abnormalities; Premature infant; Infant death
Age
From 16 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The choice of mothers in two groups of control and Intervention is done randomly using a random number table of statistics reference books. the first researcher will put a finger on the table while his eyes are closed and the touching number will be the starting point, then the researcher moves up and down, and right and left, respectively, from the numbers to obtain the sample size of use he does.
Blinding (investigator's opinion)
Single blinded
Blinding description
Mothers participating in research. The mothers of each group are unaware of the other group and the interventions they are doing.
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
Next to Milad Tower, Hemat Road
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.IUMS.REC.1395.28807
Health conditions studied
1
Description of health condition studied
Mother infant attachment in nuliparousn women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal attachment score
Timepoint
The first day of the birth of baby
Method of measurement
The avant mother infant attachment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An educational program will be conducted by a researcher and lecture and a group using a projector video for mothers during the last month of pregnancy. The training includes the first session: Primary care education for the newborn and follow-up vaccination and heel screening, Second session: Training the symptoms of the risk and disease in the newborns, and the third session: Developmental care education (touch, massage, sleepiness, lullaby, Kissing, grooming, the importance of skin-to-skin contact).
Category
Behavior
2
Description
Control group: The mothers in the control group only received the routine care of during pregnancy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam sajad hospital
Full name of responsible person
Masoumeh askari
Street address
Valiasr street, Imam sajad hospital
City
Shahriar
Province
Tehran
Postal code
3351636434
Phone
+98 21 6522 6041
Email
askari.mas28@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed kazem malakoti
Street address
Next to Milad Tower, Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
askari.mas28@yahoo.com
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 Science
Full name of responsible person
Masoumeh askari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr street, Imam sajad hospital
City
Shahriar
Province
Tehran
Postal code
3351636434
Phone
+98 21 6522 6041
Fax
Email
askari.mas28@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Masoumeh askari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr street, Imam sajad hospital
City
Shahriar
Province
Tehran
Postal code
3351636434
Phone
+98 21 6522 6041
Fax
Email
askari.mas28@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medica Science
Full name of responsible person
Masoumeh askari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr street, imam sajad hospital
City
Shahriar
Province
Tehran
Postal code
3351636434
Phone
+98 21 6522 6041
Fax
Email
askari.mas28@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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