Protocol summary

Summary
Prenatal depression is a significant predictor of postpartum depression and is detrimental to fetal development. According to the World Health Organization, depression is a leading cause of disability among women worldwide. The aim of this study is determine the comparing the effectiveness of two intervention programs, social support and integration with the health locus of control on decreasing of depression during pregnancy. Method: This study is a quasi-experimental study on 108 pregnant women in the third trimester, have been referred to health centers. Samples through a stage stratified random sample selected were divided into two groups. Educational intervention based on social support and integration with the health locus of control was 6 sessions for each group. After the first test (immediately after the intervention) and after the second test (one month after the end of treatment) was conducted to review the results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070428773N1
Registration date: 2016-08-07, 1395/05/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-07, 1395/05/17
Registrant information
Name
Malihe Pishvaei
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 9025
Email address
pishvaei.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2014-03-22, 1393/01/02
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of two intervention programs, social support and integration with the health locus of control on decreasing of depression during pregnancy
Public title
Two intervention programs, social support and integration with the health locus of control on decreasing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 26-32 weeks; ability to read and write; healthy fetus on ultrasound; aged 18 to 35 years old; lack of depression known in life; absence of pregnancy complications (bleeding, placenta previa, etc.); consent to participate in the study sample. Exclusion criteria: preterm delivery during the intervention; serious physical and psychological problems such as death of a family during the intervention; lack of participation in training courses for more than two sessions; unwillingness to continue participation in the study subjects.
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: 108
Randomization (investigator's opinion)
Randomized
Randomization description
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad
Postal code
96917937180
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
GMUIRC.1392.61

Health conditions studied

1

Description of health condition studied
Depression during pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Depression during pregnancy
Timepoint
Immediately and one month later after intervention
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS), Multidimensional Health Locus of Control Scales (MHLCS), Vaux

Secondary outcomes

1

Description
Support and health control beliefs
Timepoint
Immediately after the intervention
Method of measurement
Questionnaire Edinburgh Postnatal Depression Scale (EPDS) ,Multidimensional Health Locus of Control Scales (MHLCS), Vaux

Intervention groups

1

Description
In this study, women who were pregnant in the months 26 to 37 urban health centers for routine examination, enrolled by stratified random. Subjects with inclusion criteria were randomly divided into two groups 1 and 2 were tested. After obtaining permission from the relevant authorities and the satisfaction of the samples, questionnaires on demographic, social support and depression Edinburgh HLC theory was completed by the patients. Subjects were also declared that in case of dissatisfaction and lack of willingness to cooperate can quit the application and announce their withdrawal. The data obtained from the pre-test, the information required to prepare an intervention plan was reviewed and analyzed. The intervention began, according to the results. Test 1 and Test 2 groups of 12 to 15 were divided into categories. Average number of sessions 6 sessions per week a meeting was held for each subgroup. Researcher with intimate relationships among pregnant women, their husbands’ partnership (holding the first training session for their wives at the start of treatment), and social support did. Topics include theory HLC for your understanding, problem solving skills, decision making, self-confidence and self-esteem, assertiveness, self-efficacy and ..... education was discussed. It is important to note that the research program was set up and run that the intervention sessions in order to enhance social protection and health locus of control theory was pregnant.
Category
Lifestyle

2

Description
After the intervention and post-test, the control group was planning education programs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Public health centers affliated toGonabad University of Medical Sciences and Health Services
Full name of responsible person
Dr. Moshki
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mehdi Moshki
Position
Associate Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 9025
Fax
+98 51 5722 9025
Email
drmoshki@gmail.com
Web page address
http://sdhprc.gmu.ac.ir/homepage.html

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mehdi Moshki
Position
Associate Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 9025
Fax
+98 51 5722 9025
Email
drmoshki@gmail.com
Web page address
http://sdhprc.gmu.ac.ir/adress/adress-maghalat.html

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Malihe Pishvaei
Position
MSc
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 9025
Fax
+98 51 5722 9025
Email
sdhprc@gmail.com
Web page address
http://sdhprc.gmu.ac.ir/adress/adress-maghalat.html

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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