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Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy

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History
# Registration date Revision Id
2 2019-03-13, 1397/12/22 85861
1 2018-07-17, 1397/04/26 53027
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  • General information

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    2018-07-21, 1397/04/30
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    2018-09-11, 1397/06/20
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    2018-09-11, 1397/06/20
    Effect of group counseling on maternal fetal attachment in nulliparous women with unplanned pregnancy
    Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
    تاثیر مشاوره گروهی بر دلبستگی مادر و جنین در مادران نخست زا با حاملگی ناخواسته
    تاثیر مشاوره گروهی بر دلبستگی مادر و جنین در مادران با حاملگی ناخواسته
    Effect of group counseling on maternal fetal attachment in nulliparous women with unplanned pregnancy
    Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
    تاثیر مشاوره گروهی بر دلبستگی مادر و جنین در مادران نخست زا با حاملگی ناخواسته
    تاثیر مشاوره گروهی بر دلبستگی مادر و جنین در مادران با حاملگی ناخواسته
    Pregnant women with unplanned pregnancy in control group will be blind.

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Alborz University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی البرز
    Full name of responsible person - English: Dr. Mohammad Nooriseppehr
    Full name of responsible person - Persian: دکتر محمد نوری سپهر
    Street address - English: North Taleghani street, Azimyeh, Karaj
    Street address - Persian: عظیمیه، طالقانی شمالی، کرج
    City - English: karaj
    City - Persian: کرج
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 3149779453
    Phone:
    Fax:
    Email: dr.noorisepehr@abzums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad Nooriseppehr
    Full name of responsible person - Persian: دکتر محمد نوری سپهر
    Street address - English: North Taleghani street, Azimyeh, Karaj
    Street address - Persian: عظیمیه، طالقانی شمالی، کرج
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 3149779453
    Phone: +98 26 3464 3176
    Fax:
    Email: dr.noorisepehr@abzums.ac.ir
    Web page address:
    empty
    Yes
    Alborz University of Medical Sciences
    Karaj University of Medical Sciences
    دانشگاه علوم پزشکی البرز
    دانشگاه علوم پزشکی کرج

  • Trial results

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    Background and purpose: Improving the emotional relationship between mother and fetus, especially in unwanted pregnancy, is associated with many positive consequences for mother and child. Therefore, the present study aimed at determining the effect of group counseling on maternal-fetal attachment in mothers with unwanted pregnancy. Methodology: This study was a randomized clinical trial. Samples were 80 mothers with unwanted pregnancy who referred to health centers of Karaj during 28 to 34 weeks who were randomly assigned into two groups of intervention (N = 40) and control group (N = 40). In the intervention group, four weekly group counseling sessions were held to create maternal-fetal attachment and the control group received routine care. General Health Questionnaire and Cranley questionnaire were used to assess the attachment of mother to fetus before and two weeks after counseling. Comparison of maternal-fetal attachment scores between the two groups and between the groups was done by student’s t-test and paired t-test. Covariance analysis was performed to evaluate the effect of intervention and the degree of pregnancy. Statistical analysis was performed using SPSS software version 22. Findings: There were no significant difference between the two groups in terms of general health scores and attachment of mother to fetus before intervention, but after the intervention, the mean scores of maternal-fetal attachment in the intervention group had a significant difference with the control group (p<0.001); ANCOVA test indicated that attachment scores was significant in terms of intervention and pregnancy group. Maternal-fetal attachment scores in the primiparous group has increased more than multiparous group (p=0.041). Conclusion: Considering the effectiveness of group counseling in improving maternal-fetal attachment in unwanted pregnancy, it can be used in prenatal care. Keywords: Maternal-fetal attachment, attachment behaviors, unwanted pregnancy, unplanned pregnancy, group counseling
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    زمینه و هدف : تقویت ارتباط عاطفي بین مادر و جنین بویژه در بارداری ناخواسته با پیامدهای مثبت بسیاری برای مادر و کودک همراه است. لذا این مطالعه با هدف تعیین تاثیر مشاوره گروهی بر میزان دلبستگی مادر و جنین در مادران با حاملگی ناخواسته انجام شد. روش کار : این پژوهش يك مطالعه كارآزمايي باليني تصادفی بود. نمونه ها 80 نفر مادر با بارداری ناخواسته مراجعه کننده به مراکز سلامت شهر کرج در هفته 28 تا 34 هفته بودند که به صورت تخصیص تصادفي به دو گروه مداخله (40 نفر) وگروه کنترل (40 نفر) تقسيم شدند. در گروه مداخله، چهار جلسه مشاوره گروهی هفتگی برای ایجاد دلبستگی مادر و جنین برگزار شد و گروه کنترل مراقبت روتین دریافت نمود. پرسشنامه سلامت عمومی و نیز پرسشنامه کرانلی برای سنجش دلبستگی مادر به جنین قبل و دو هفته بعد از مشاوره تکمیل شد. مقایسه میانگین نمرات دلبستگي مادر و جنين بين دو گروه و درون گروه ها با آزمون تی استیودنت و تی زوجی انجام شد. آنالیز کوواریانس برای بررسی اثر مداخله، و رتبه بارداری انجام شد. تحلیل آماری با نرم افزار SPSS نسخه 22 انجام شد. یافته ها: دو گروه از نظر نمره سلامت عمومی و دلبستگی مادر به جنین قبل از مداخله با یکدیگر تفاوت معنی دار اماری نداشتند اما بعد از مداخله میانگین نمرات دلبستگی مادر به جنین در گروه مداخله تفاوت آماری معنی داری با گروه كنترل داشت (p<0.001)؛ آزمون ANCOVA نشان داد نمره دلبستگی بر حسب مداخله و گروه حاملگی معنی دار بود. نمره دلبستگی در گروه نخست زا نسبت به چندزا افزایش بیشتری نشان داده است (p=0.041). نتیجه گیری: با توجه به اثربخشی مشاوره گروهی در ارتقای میزان دلبستگي مادر به جنین در بارداری ناخواسته، در مراقبت هاي پره ناتال می تواند مورد استفاده قرار گیرد. واژگان کلیدی : دلبستگی مادر و جنین، رفتارهای دلبستگی، بارداری ناخواسته، بارداری برنامه ریزی نشده، مشاوره گروهی

Protocol summary

Study aim
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: 2019-04-09, 1398/01/20
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
2018-07-21, 1397/04/30
Actual recruitment end date
2018-09-11, 1397/06/20
Trial completion date
2018-09-11, 1397/06/20
Scientific title
Effect of group counseling on maternal fetal attachment in women with unplanned pregnancy
Public title
Effect of group counseling on maternal fetal attachment in 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
No information
Sample size
Target sample size: 80
Actual sample size reached: 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
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
Karaj 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
+98 26 3464 3176
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Up to a week after sending the email address
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