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The effect of Happiness on the Psychological capital of Middle aged women

Protocol summary

Study aim
Determining the The effect of Happiness on the Psychological capital of Middle aged women of kashan, 2020
Design
clinical trial with control group and blinded statistical analyzer
Settings and conduct
Clinical trial study will be conducted in two experimental group- 30 middle aged women (happiness planning) and control group- 30 middle aged women(without intervention) in Selected Health Centers of Kashan City (Muslim Ibn Aqil and Sadeghzadeh)
Participants/Inclusion and exclusion criteria
Having informed consent to participate in research, Age 40-65 years, Living in Kashan, Iranian nationality, The ability of talking and listening, Ability to communicate in Persian, Earning a score of less than 112 (on a scale of 156-26) From the psychological capital tools of McGee et al., Having the physical ability to attend meetings, No known mental illness (self-reporting), No known mental retardation, Failure to deal with acute and serious stress in the last 6 months (death of relatives, serious illness or relatives, etc).
Intervention groups
The intervention group will be received a Happiness intervention based on the Fordyce protocol for 4 weeks, 8 sessions of 90 minutes. The first session will begin with welcoming, presenting the researcher to members, reviewing goals, reviewing the structure of the sessions, and the main rules. After that the questionnaires will be completed by the participants. At the beginning of each session, the researcher invites the participants to active participation in discussions, and at the end of each session, the participants will be given homework according to the protocol regarding the subject of the meeting. At the end of each session, the hour and the title of the next session will be indicated. Control group will not receive any intervention.
Main outcome variables
Psychological capital

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100211003329N4
Registration date: 2020-02-27, 1398/12/08
Registration timing: registered_while_recruiting

Last update: 2020-02-27, 1398/12/08
Update count: 0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Zahra Sooki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
sooki_za@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-04-24, 1399/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Happiness on the Psychological capital of Middle aged women
Public title
The effect of Happiness on the Psychological capital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in research Age 40-65 years Living in Kashan Iranian nationality The ability of talking and listening Ability to communicate in Persian Earning a score of less than 112 (on a scale of 156-26) From the psychological capital tools of McGee et al. Having the physical ability to attend meetings
Exclusion criteria:
Known mental illness (self-reporting) Known mental retardation Deal with acute and serious stress in the last 6 months (death of relatives, serious illness or relatives, etc.)
Age
From 40 years old to 65 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
Samples will be assigned two groups Using the block randomization technique by the software sealed Envelope Ltd.2017 Available from through www.sealedenvelope.com,12 blocks ( 6 blocks with 6 people and 6 block with 4 people) were defined. The blocks are divided into 2 categories based on the list taken from the site and randomly each category of blocks will be selected from one center. After identifying the members of the groups by random allocation, for people in intervention group, group intervention will be conducted in two separate groups in each center.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer is unaware of experimental and control group characteristics
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715985191
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.041

Health conditions studied

1

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

Primary outcomes

1

Description
Psychological capital
Timepoint
Start, Immediately after the intervention and one month later
Method of measurement
( Psychological capital Questionnaire (McGee et al)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive a group happiness program based on the Fordisee protocol during 8 sessions of 90 minutes (2 sessions per week at least two days apart). The first session begins with welcoming the members, introducing the group leader to the members and members to each others, discussing the goals, reviewing the structure of the meetings, the rules governing the group, and the duties and responsibilities of the members and the group leader.The goals of the sessions in the intervention group from the first to the eighth meeting respectively including; the need for happiness in life, Importance of leisure and entertainment, Increasing intimacy and social relationships, Stop worrying and living in the present time, lowering the level of optimism and positive thinking and optimism, planning and organization affairs, healthy personality and self-importance and the importance of happiness that can be achieved through group discussion, practicing group, home and community exercises. At the beginning of each session the members report and discuss the exercises and tasks, then work on the purpose of the meeting. At the end of each session, members of the group will be welcomed and the time and title of the next meeting will be indicated.
Category
Treatment - Other

2

Description
Control group: The control group will have no intervention about happiness and will only receive routine care at the health center including assessment of chronic diseases and cancers, etc.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers in Kashan
Full name of responsible person
Fahime sadeghi
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0021
Email
Fahime.sadeghi.6368@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0021
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fahime sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0021
Email
sadeghi-f@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Khadijeh Sharifi- Zahra Tagharrobi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0021
Email
sharifi_kh@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sooki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0021
Email
sooki_za@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be received in the form of a questionnaire from the participants and will eventually be shown in the table.
When the data will become available and for how long
6 month after publication
To whom data/document is available
for everyone who interested in the subject
Under which criteria data/document could be used
no specific condition is required
From where data/document is obtainable
sharifi81k@yahoo.com Dr. Khadijeh Sharifi
What processes are involved for a request to access data/document
Once the email is received, it will be answered
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