Comparison of the effectiveness and non effectiveness of psycho-educational intervention in couples and pregnant women groups on their mental health in selected health centers of Isfahancity,2015
This study will be done with aim to comparing the effects of psycho-educational intervention in couples and pregnant women groups on their mental health in selected health centers of Isfahan city in 2015.this is a non blinded clinical trial. The study population will be included pregnant women with gestational age of 21-25 that refers to Navab and Amir Hamzeh and Ibn Sina centers in Isfahan, that 120 persons will selected and randomly (by lottery in three experimental and control groups (two experimental groups and one control group) will be placed. At the beginning of the study General Health Questionnaire (GHQ) and depression, anxiety and stress questionnaire ((Dass42) will provided for the three groups. Then the experimental groups (group of couples and pregnant women) within 4 weeks for 90 minutes will received the mental training and the control group will not receive any education, two weeks after the end of the study, questionnaires will be provided to participants in all three groups and mental health variables, depression, anxiety and stress in all three groups will be compared with each other.
Inclusion criteria: Patient's written consent; Pregnant women with wanted pregnancies and first pregnancy; Singleton pregnancy with gestational age 21 to 25 weeks; No history of infertility and infertility treatment.
Exclusion criteria: Disease or particular problem during the study; Preterm delivery; The occurrence of sudden and serious stress before completing a second phase questionnaires like (death of relatives, etc.)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012426174N1
Registration date:2016-03-15, 1394/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-15, 1394/12/25
Registrant information
Name
Zahra Akbarian
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 3339
Email address
zahraakbarian2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Expected recruitment start date
2016-03-15, 1394/12/25
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness and non effectiveness of psycho-educational intervention in couples and pregnant women groups on their mental health in selected health centers of Isfahancity,2015
Public title
The effect of mental training in pregnancy in couples and pregnant women on women's mental health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient's written consent; Pregnant women with wanted pregnancies and first pregnancy; Singleton pregnancy with gestational age 21 to 25 weeks; No acute obstetric and pregnancy-related problems; Lack of psychological illnesses ; No drug addiction of pregnant woman or her husband ; Lack of serious stress in the past 6 months; No history of infertility and infertility treatment.
Exclusion criteria: Disease or particular problem during the study; Preterm delivery; The occurrence of sudden and serious stress before completing a second phase questionnaires like (death of relatives, etc.)
Age
From 15 years old to 32 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly draw a card
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
ir.mui.rec.1394.3.556
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Mental health
Timepoint
Baseline and two weeks after the end of the study (sixth week)
Method of measurement
According to the General Health Questionnaire (GHQ)
2
Description
Depression
Timepoint
Baseline and two weeks after the end of the study (sixth week)
Method of measurement
According to depression, anxiety and stress (Dass 42)questionnaire
3
Description
Anxiety
Timepoint
Baseline and two weeks after the end of the study (sixth week)
Method of measurement
According to depression, anxiety and stress (Dass 42)questionnaire
4
Description
Stress
Timepoint
Baseline and two weeks after the end of the study (sixth week)
Method of measurement
According to depression, anxiety and stress (Dass 42)questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental groups at the beginning of the study General Health Questionnaire (GHQ) and depression, anxiety and stress questionnaire ((Dass42) will be provided to participants (group of couples and pregnant women).Then within 4 weeks for 90 minutes will received the mental training, two weeks after the end of the study, questionnaires will be provided to participants and mental health variables, depression, anxiety and stress in both groups will be studied.
Category
Behavior
2
Description
In the control group at the beginning of the study General Health Questionnaire (GHQ) and depression, anxiety and stress questionnaires ((Dass42) will be provided to participants but will not receive any education and two weeks after the end of the study, questionnaires will be provided to participants
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Nawab Safavi
Full name of responsible person
Zahra Akbarian
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Street of Hezarjarib
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Akbarian
Position
Student of Ms. Midiwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery,Esfahan University of Medical Sciences ,Hezarjarib Street
City
Esfahan
Postal code
Phone
+98 31337922906
Fax
Email
zahraakbarian2013@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Kohan
Position
Ph.D of reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Postal code
Phone
+98 31337923060
Fax
Email
kohan@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Akbarian
Position
Student of Ms. Midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Postal code
Phone
+98 31337923060
Fax
Email
zahraakbarian2013@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)