Protocol summary

Study aim
Determining the Effect of Group Counseling with Positive Psychological Approach on Psychological Capital and Quality of Life of Postmenopausal Women.
Design
Positive Psychological Interventions will be presented to the intervention group once a week for 8 sessions of 75-90 minutes.The number of participants in each session is 12. At the beginning, after the end of the last counseling session and two months after the end of the sessions, the questionnaires will be provided to the participants. After the data analysis, four consultation sessions will be held for the control group.
Settings and conduct
The research study population is the menopausal women that refer to healthcare of Takab city.
Participants/Inclusion and exclusion criteria
Entry criteria: At least primary education, Resident of Takab city, The age between 48-60, Lack of menstruation in the past year, Not taking hormones and smoking for the past 6 months, No history of hysterectomy and ophthalmic surgery, Having mental health, No major stress in the last six month, No having acute and chronic disease, Agree to participate in the research Exclude criteria: Don't complete the questionnaire, Having the disease during the study, The occurrence of major stressful events during the research, reluctance to continue to participate in the study, non-attendance at more than two counseling sessions, Occurrence of abnormal bleeding during the study.
Intervention groups
for the intervention group, the counseling will be held in groups of eight sessions of 75-90 minutes per week with a positive approach. The number of members in the group counseling of the two groups will be 12 and in one group will be 11, and at the end of each session, homework will be given to the participants.
Main outcome variables
Psychological Capital, Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200210046448N1
Registration date: 2020-07-05, 1399/04/15
Registration timing: registered_while_recruiting

Last update: 2020-07-05, 1399/04/15
Update count: 0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
leila rastegari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8402
Email address
lrastegari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Counseling With Positive Psychology Approach on Psychological Capital and Quality and Life in Postmenopausal Women.
Public title
The Effect of Group Counseling With Positive Psychology Approach on Psychological Capital and Quality of Life in Postmenopausal Women.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Resident of Takab city Age between 48-60 Lack of menstruation in the past year Not taking hormones and smoking for the apst 6 months No history of hysterectomy and oophorectomy Having mental health No major stress in the last six months Lack of acute and chronic disease Agreement to participate in the research
Exclusion criteria:
Age over 60 and under 48 years History of hysterectomy and ophorectomy Having an acute and chronic illness History of relatives' deaths in the last six months Getting mentally ill and taking psychiatric medications substances Participation in training sessions and similar consultations
Age
From 48 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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. Then, using the random numbers table, the selection of samples will continue until the sample size reaches 70 people.
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
Ethics committee of Zanjan University of Medical Sciences
Street address
School of Nursing and Midwifery , Haj Ahmad Mahdavi ,Karmandan town ,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
IR.ZUMS.REC.1398.455

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 of Intervention, The end of Consulting Session, Two Months After the Intervention
Method of measurement
Psychological Capital Questionnaire

2

Description
Quality of Life
Timepoint
Before of Intervention, The end of Consulting Session, Two Months After the Intervention
Method of measurement
Quality of Life Questionniare

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 75-90 minutes, will be held a weekly one session. The number of members in the group consultation will be 12, and at the end of each session homework assignments will be given to participants.
Category
Treatment - Other

2

Description
Control group: After the intervention If the participants in the control group wish, 4 positive psychological counseling sessions will be held for them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Takab County Health Care Center
Full name of responsible person
Shifteh Hashem Zade
Street address
Health center, Enghelab Street, Takab
City
Takab
Province
West Azarbaijan
Postal code
5991669689
Phone
+98 44 4552 2871
Email
shifteh.h@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Dinmohammadi
Street address
Zanjan University of Medical Science,Azadi Square,
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
shifteh.h@yahoo.com
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan University of Medical Science
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
Shifteh Hashemzade
Position
Midwifery Counseling Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery , Karmandan Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3314 8318
Fax
+98 24 3314 8319
Email
shifteh.h@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Leila Rastgari
Position
Educator, Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Karmandan Boulevard , Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8319
Fax
+98 24 3314 8319
Email
lrastegari@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shifteh Hashemzade
Position
Master Degree Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Karmandan Boulevard,
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3314 8318
Fax
+98 24 3314 8319
Email
shifteh.h@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publishable data include of Published articles, General Result of Interpretation
When the data will become available and for how long
Since 1400
To whom data/document is available
For Researchers and Students at Academic and Scientific Institution.
Under which criteria data/document could be used
Get Permission from Authors.
From where data/document is obtainable
Executor of the Project and Author.
What processes are involved for a request to access data/document
Contact or Send Email to Executor or Author.
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