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The Effect of Group Consulting with Positive Psychological Approach on Psychological Capital and Quality of Life in Pregnant Women

Protocol summary

Study aim
Determining the Effect of Group Consulting with Positive Psychological Approach on Psychological Capital and Quality of Life in Pregnant Women
Design
Positive Psychological Interventions will be offered twice a week in 8 sessions of 90-60 minutes. The number of participants in each session is 10 people. In the beginning and after the consultation sessions, the questionnaires will be provided to the participants. The questionnaires will be re-submitted to the participants six weeks after the last consultation. The control group will receive routine pregnancy care.
Settings and conduct
The research population is pregnant women referring to Prenatal Preparatory Counseling Centers, Comprehensive Health Centers, Women's Clinics.
Participants/Inclusion and exclusion criteria
Entry criteria: Pregnancy age 14 to 28 weeks of gestation, Completion of informed consent form, No history of complications and problems associated with pregnancy, No medical and surgical diseases, no mental illness and cognitive impairment, no psychiatric drugs, no drugs And fluent, having at least third-level guidance, familiarity with Persian language, non-attendance at training sessions and similar consultations. Exclude criteria: Exit criteria include: reluctance to continue to participate in the study, non-attendance at more than two counseling sessions, birth-related complications or termination of pregnancy, medical and surgical complications. The occurrence of major stressful events during the research.
Intervention groups
In this research, an easy sampling method was used and then 60 people with the inclusion criteria of randomly assigned blocking method would be divided into two groups of intervention and control. The number of members in each group is 30.
Main outcome variables
Psychological capital and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160521027994N6
Registration date: 2019-01-28, 1397/11/08
Registration timing: prospective

Last update: 2019-01-28, 1397/11/08
Update count: 0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Consulting with Positive Psychological Approach on Psychological Capital and Quality of Life in Pregnant Women
Public title
Impact of counseling on psychological capital and quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 14 to 28 weeks of pregnancy Completion of informed consent form Absence of history of complications and problems associated with pregnancy Absence of medical and surgical diseases Non-occurrence of mental illness and cognitive impairment Non-use of psychiatric drugs, narcotics and psychotropic drugs Having at least third-level guidance Familiarity with Persian language Non-attendance at training sessions and similar consultations
Exclusion criteria:
Gestational age less than 14 and older than 28 weeks of gestation Failure to complete informed consent form History of complications and problems associated with pregnancy Medical and surgical diseases Mental illness and cognitive impairment Use of psychiatric drugs, drugs and psychotropic substances Participation in training sessions and similar consultations
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The collected samples will be divided into two intervention and control groups using randomized block 4. In each block, two assignments will be assigned to the intervention group and two allocations for the control group, which will create a total of 6 modes, each of which will be assigned a number from 1 to 6, then the random selection of numbers 1 to 6 will continue to be continued. It found the sample size to reach 60.
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
Zanjan Medical Uneversity
Street address
Zanjan Azadi Square
City
zanjan
Province
Zanjan
Postal code
4513956113
Approval date
2019-01-10, 1397/10/20
Ethics committee reference number
IR.ZUMS.REC.1397.308

Health conditions studied

1

Description of health condition studied
Psychological capital
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Psychological capital
Timepoint
Before the intervention, the last consultation session and six weeks after the end of the intervention
Method of measurement
Psychological Capital Questionnaire

2

Description
quality of life
Timepoint
Before the intervention, the last consultation session and six weeks after the end of the intervention
Method of measurement
Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consultation with a positive psychology approach for the intervention group in a group and eight sessions of 60-90 minutes, will be held a weekly two sessions. The number of members in the group consultation will be 10, and at the end of each session homework assignments will be given to participants.
Category
Other

2

Description
Control group: In the control group, routine pregnancy care will be performed. Positive psychological counseling sessions will be held for them if they wish the participants in the control group after the intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pre-natal Preparatory Counseling Centers, Comprehensive Health Centers, Women's Clinics
Full name of responsible person
Mansureh Mostafai
Street address
Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
mostafai554@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Doctor Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
khoosheh@zums.ac.ir
Grant name
tesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mansureh Mostafai
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
mostafai554@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgoli Khooshehchin
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
khoosheh@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mansureh Mostafai
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
mostafai554@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
The release program is not yet known
When the data will become available and for how long
The release program is not yet known
To whom data/document is available
The release program is not yet known
Under which criteria data/document could be used
The release program is not yet known
From where data/document is obtainable
The release program is not yet known
What processes are involved for a request to access data/document
The release program is not yet known
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