The effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
Design
This study is a randomized clinical trial that will be conducted on 80 pregnant women with unplanned pregnancy. Forty pregnant women randomly ( block randomization) will be allocated to each group. Blindness does not take place.
Settings and conduct
Sampling will be done in a two-stage stratified process from comprehensive health centers. From each class, four centers will be selected by cluster sampling, and randomly 2 centers will be considered for intervention groups and 2 centers for control group. The names of the centers will be written in a separate sheets and then place inside the bag. The first two centers will be for intervention groups and the next two centers for control group. The main researcher will be in the centers allocated for intervention group in odd days and in the centers allocated for control group in even days and will randomly select 10 participants.
Participants/Inclusion and exclusion criteria
Include criteria: age between 18 to 35; unplanned pregnancy; education level at guidance; single pregnancy; no drug abuser; gestational age between 28 to 34 weeks; and living with husband.
No include criteria: having underlying medical conditions and obstetrical complications such as: bleeding; diabetes; hypertension; preterm labor.
Intervention groups
Intervention group will receive four 60 minutes sessions group counseling weekly during third trimester of pregnancy. Control group will just receive routine care. The questionnaires will be fulfilled by mothers two weeks after counseling sessions, and a short counseling session will be held at same day.
Main outcome variables
Maternal fetal attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031662N5
Registration date:2018-07-17, 1397/04/26
Registration timing:prospective
Last update:2018-07-17, 1397/04/26
Update count:1
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-18, 1397/04/27
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling on maternal fetal attachment in nulliparous women with unplanned pregnancy
Public title
Effect of group counseling on maternal fetal attachment in nulliparous women with unplanned pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 35 years old
Premature birth and unwanted pregnancy
Having at least guidance literacy
Single pregnancy
Not having abuse and drug addiction
Gestational age between 28 and 34 weeks
Living with spouse
Exclusion criteria:
Having underlying medical illnesses
Complications such as bleeding, diabetes, hypertension and early delivery
Severe psychological problems
Absence of mother to receive 2 consecutive consultations
Unwillingness to continue attending meetings
Twin
Age
From 18 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
80 samples will include in study; 40 women in intervention and 40 in control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Pregnant women with unplanned pregnancy in control group will be blind.
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 Sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghai square
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.ABZUMS.REC.1397.017
Health conditions studied
1
Description of health condition studied
maternal fetal attachment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
maternal fetal attachment
Timepoint
before intervention, 2 weeks after intervention
Method of measurement
cranley questinnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group participates in 4 group counseling sessions on maternal and fetal attachment that runs once a week and in groups of 10 people. Duration of each session is about 1 hours.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Fajr Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
Milad 1,
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3470 3204
Email
siminjangjoo24@yahoo.com
2
Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
Mysam 2 ,
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3480 5863
Email
siminjangjoo24@yahoo.com
3
Recruitment center
Name of recruitment center
Amozgar Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
pelak 7
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3730 7590
Email
siminjangjoo24@yahoo.com
4
Recruitment center
Name of recruitment center
Golzar Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
45 metri golshar
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3351 5758
Email
siminjangjoo24@yahoo.com
5
Recruitment center
Name of recruitment center
Aadl Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
Pelal 511,
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3453 1814
Email
siminjangjoo24@yahoo.com
6
Recruitment center
Name of recruitment center
Zafar Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
pelak 35
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3456 1798
Email
siminjangjoo24@yahoo.com
7
Recruitment center
Name of recruitment center
Valad abad bozorg Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
Roberoye chamran 1,
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3631 3437
Email
siminjangjoo24@yahoo.com
8
Recruitment center
Name of recruitment center
Nabovvat Health Center
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Street address
koche mysam,
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3444 7429
Email
siminjangjoo24@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Nooriseppehr
Street address
North Taleghani street, Azimyeh, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alborz 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
School of Nursing and Midwifery-Alborz University of Medical Sciences
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Position
BsC. in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Square of Prophethood, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3430 4433
Email
siminjangjoo24@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery-Alborz University of Medical Sciences
Full name of responsible person
Dr. Razieh Lotfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
midwifery
Street address
1st Street Golestan, Eshteraki Boulevard, Baghestan, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 912 765 5855
Email
lotfi_razieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery- Alborz University of Medical Sciences
Full name of responsible person
Simin Jangjou sabet khoshkebejari
Position
BsC. in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Square of Nabovat, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 1034 3455
Email
siminjangjoo24@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
he total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
scientific studies
From where data/document is obtainable
send an email to Dr. Razieh Lotfi.
What processes are involved for a request to access data/document