The aim of the present study will be examining the training of immunization against the stress on the individual's sense of cohesion and the psychological distress in pregnant women
Design
This study is a nonblinded clinical trial. The research population will be included all pregnant women referred to Imam Sari hospital. 30 pregnant women will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
The study will be conducted in Imam Sari hospital. The control group and the experimental group will complete psychological distress and sense of coherence questionnaire.
Participants/Inclusion and exclusion criteria
Entry requirements to study would be to earn a score down in the individual sense of cohesion and earn a high score on the scale of psychological distress
Intervention groups
The experimental group was given a stress inoculation training about 8 sessions, once a week for 90 minutes and the control group did not receive training
Main outcome variables
psychological distress and sense of coherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190319043092N1
Registration date:2019-08-03, 1398/05/12
Registration timing:retrospective
Last update:2019-08-03, 1398/05/12
Update count:0
Registration date
2019-08-03, 1398/05/12
Registrant information
Name
Ghodratollah Abbasi
Name of organization / entity
Islamic Azad University, Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 11 3444 5863
Email address
gh_abbasi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of stress inoculation training on individual sense of coherence and psychological distress in pregnant women
Public title
effectiveness of stress inoculation on individual sense of coherence and psychological distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
low score on the scale of sense of coherence
high score on the scale of psychological distress
Pregnancy week 31 or 32
The lack of experience in training classes
The lack of physical disease
The lack of a history of psychiatric illness
Exclusion criteria:
High risk pregnancy (preeclampsia, hemorrhage, miscarriage risk)
preterm delivery (delivery earlier than 37 weeks of pregnancy)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women were replaced by simple random
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
Islamic Azad University- Sari Branch
Street address
Floor 5, Medical Bldgs, Azad University, Farah Abad Rd., Khazar Sq, Sari
City
Sari
Province
Mazandaran
Postal code
19318-48161
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.IAU.SARI.REC.1397.029
Health conditions studied
1
Description of health condition studied
Distress in pregnancy
ICD-10 code
O75.0
ICD-10 code description
Maternal distress during labor and delivery
Primary outcomes
1
Description
sense of coherence
Timepoint
Before the study and immediately after the intervention
Method of measurement
Antonovsky's sense of coherence scale
2
Description
psychological distress
Timepoint
Before the study and immediately after the intervention
Method of measurement
The scale of psychological prishani Kessler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive stress inoculation training about 8 sessions, once a week for 90 minutes.
Category
Behavior
2
Description
Control group: The control group will receive the ward usual care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sari hospital
Full name of responsible person
Farah masihpor
Street address
Floor 2, Imam Khomeini Hospital, Amir Mazandarani St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Email
fmasihpour19@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
mohamad farsi
Street address
Floor 5, Office Bldgs, Azad University, Farah Abad Rd, Khazar Sq
City
Sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 11 3303 2891
Email
moh_farsi@iausari.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ghodratollah Abbasi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Floor 5, Human Sciences Bldgs, Azad University, Farah Abad Rd, Khazar Sq
City
Sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 11 3444 5836
Email
abasighodrat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghodratollah Abbasi
Position
Sari
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Floor 5, Human Sciences Bldgs, Azad University, Farah Abad Rd, Khazar Sq
City
Sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 11 3444 5836
Email
abasighodrat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghodratollah Abbasi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Floor 5, Human Sciences Bldgs, Azad University, Farah Abad Rd, Khazar Sq
City
Sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 11 3444 5836
Email
abasighodrat@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail