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Effects of Counselling on Maternal-Fetal Attachment and Maternal Stress among Primigravida Women Attended to Health Care Centers in Hamadan, 2015

Protocol summary

Summary
Objective of this study is to investigate effects of Counselling on Maternal-Fetal Attachment and Maternal anxiety during pregnancy. Population of the study are primigravida women attended to health care centers in Hamadan in 2015. Samples are women within 30-32 week of pregnancy with inclusion criteria. Firstly, women will complete consent form. Secondly, participants will selected by random sampling and will allocated randomly in case or control group. Two groups will match on age, socioeconomic status, and having no education for childbearing in pregnancy. Case group are primi-gravid mothers who will receive routine prenatal care and furthermore will receive small group consulting every week since 32th week of pregnancy for four sections. Consulting contents include: understanding of physiological changes in pregnancy, risk factor signs, instruction of mother-fetal attachment, palpate fetal quickening and count fetal movement by mothers themselves. Control group only will take routine prenatal care during pregnancy. Instruments of data collections are: 1- demographic status ( age, education, job, etc. ), 2- mother fetal attachment questionnaire developed by Cranley , 3- Spielberger anxiety questionnaire. Two groups will compare for mother-fetal attachment and anxiety before (32th week) and after study (36th week). Follow-up will conduct on 38 th week of pregnancy in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010910426N4
Registration date: 2015-02-14, 1393/11/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Counselling on Maternal-Fetal Attachment and Maternal Stress among Primigravida Women Attended to Health Care Centers in Hamadan, 2015
Public title
Effects of Counselling on Maternal-Fetal Attachment and Maternal Stress among Primigravida Women Attended to Health Care Centers in Hamadan, 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: wanted first pregnancy, no history of medical or obstetrics problems such as diabetes, per-eclampsy, bleeding, multiple pregnancy, premature labor, PROM, low to moderate anxiety in pregnancy. Exclusion criteria: having medical or obstetrics problems during study such as diabetes, per-eclampsy, bleeding, multiple pregnancy, premature labor, PROM, sever anxiety during pregnancy, unwilling to participate in consulting classes.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences- Shahid Fahmideh Street -Counterpoin of Mardom Park- Hamadan
City
Hamadan
Postal code
Approval date
2015-01-28, 1393/11/08
Ethics committee reference number
16/35/9/5510 پ

Health conditions studied

1

Description of health condition studied
Maternal mental care related to pregnancy
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified

Primary outcomes

1

Description
Mother-fetal attachment
Timepoint
week 32-36-38
Method of measurement
Cranely Questionnare

Secondary outcomes

1

Description
Mother anxiety
Timepoint
week 32-36-38
Method of measurement
Spielberger questionnare

Intervention groups

1

Description
Case group are primi-gravid mothers who will receive routine prenatal care and furthermore will receive small group consulting every week since 32th week of pregnancy for four sections. Consulting contents include: understanding of physiological changes in pregnancy, risk factor signs, instruction of mother-fetal attachment, palpate fetal quickening and count fetal movement by mothers themselves.
Category
Behavior

2

Description
Control group only will take routine prenatal care during pregnancy.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health care centers in Hamadan city
Full name of responsible person
Street address
Health Care Center- Ayande Sazan Street- Behand Ekbatan Hospital- Jahad Square-Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmideh Street -Counterpoin of Mardom Park- Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery- Hamadan University of Medical Sciences- Shahid Fahmideh Street -Counterpoin of Mardom Park- Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0051
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery- Hamadan University of Medical Sciences- Shahid Fahmideh Street -Counterpoin of Mardom Park- Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0051
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery- Hamadan University of Medical Sciences- Shahid Fahmideh Street -Counterpoin of Mardom Park- Hamadan
City
Hamadan
Postal code
Phone
+98 988138380051
Fax
Email
parsa@umsha.ac.ir
Web page address

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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