Determining the effectiveness of positive psychology intervention on health-promoting lifestyle in postmenopausal women
Design
Clinical trial, randomized, randomization by sealed envelope on 70 participants.
Settings and conduct
After obtaining the necessary permits to determine the health centers, the researcher referred to the Urmia city health center. From each center, unequal volumes will be selected according to the menopausal women covered by that center. 35 members of the intervention group will be assigned to five groups of seven people and will have six sessions, each session lasting ninety minutes, and one session per week for a total of six weeks in health centers selected by the researcher as a group under positive psychotherapy. will be placed, while no intervention will be done for the control group.
نماد «مورد تأیید انجمن»
Participants/Inclusion and exclusion criteria
45-60 years old, no use of sleeping pills and antidepressants, tobacco and alcohol
Willingness to participate in the study, Not suffering from mental illnesses that require hospitalization (such as psychosis), Not receiving medication or any treatment for menopause symptoms
Intervention groups
35 members of the intervention group will be assigned in five groups of seven people and will undergo positive psychotherapy in six sessions at health centers selected by the researcher, while no intervention will be done for the control group.
Main outcome variables
Health-promoting lifestyle in postmenopausal women
نماد «مورد تأیید انجمن»
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220710055428N1
Registration date:2022-08-04, 1401/05/13
Registration timing:prospective
Last update:2022-08-04, 1401/05/13
Update count:0
Registration date
2022-08-04, 1401/05/13
Registrant information
Name
Sara Mehrpooya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3343 9876
Email address
saramehrpooya1359@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-11, 1401/05/20
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study survey of The effect on positive psychology intervention on health-promoting lifestyle in postmenopausal women
Public title
Study survey of The effect on positive psychology intervention on health-promoting lifestyle
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-60 years (at least 12 full months have passed since their last period)
Not using sleeping pills and antidepressants, tobacco and alcohol
Willingness to participate in the study
Being literate in reading and writing
Not suffering from mental illnesses that require hospitalization (such as psychosis)
Not receiving medication or any treatment for menopause symptoms
Exclusion criteria:
Traveling or changing the place of residence during the intervention
Having more than two absences in meetings
Participation in other psychological treatments at the same time.
Age
From 45 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
In this experimental study, the research population includes 70 postmenopausal women who refer to the comprehensive health centers of Urmia city, who have health records registered in the Sib system, and they were contacted using the telephone numbers of the selected people and given explanations of The reasons and methods of conducting the research are given to them and they are invited to participate in the research.70 menopausal women willing to participate in the research will be selected as the research sample in a targeted manner and will be randomly assigned(The choice is such that we will have 70 sealed envelopes, 35 envelopes will contain A and 35 envelopes will contain B).The envelopes will be shuffled and will not be in any particular order.When the reference is contacted and after checking the criteria for entering the study and obtaining the consent form to conduct the study, a staff member at the comprehensive health centers is asked to choose an envelope from among 70 envelopes, and in this way it is determined in which group this person will be placed.If a sample did not meet the inclusion criteria, or was unwilling to participate in the study or unavailable, the next person would be randomly replaced.
نماد «مورد تأیید انجمن»
نماد «مورد تأیید انجمن»
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The first group is the intervention group, which will be subjected to positive psychology intervention for six weeks and one ninety-minute session per week.The second group is the control group and no special intervention is done on them and they receive routine care from the Comprehensive Health Center and at the end of the study an educational text will be prepared and will be available to them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Emergency room, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-06-29, 1401/04/08
Ethics committee reference number
IR.UMSU.REC.1401.135
Health conditions studied
1
Description of health condition studied
Health-promoting lifestyle in postmenopausal women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health promoting lifestyle
Timepoint
Before and after the six-week intervention
Method of measurement
Walker's standard health promoting lifestyle questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:35 menopausal women who have passed 12 months since their last menstrual period will be subjected to positive psychotherapy protocol (Parks-Shiner, 2009) which includes 6 sessions of 90 minutes, one session per week for 6 weeks.35 people in the intervention group will be divided into five groups of 7 people If the restrictions related to the covid disease continue, psychotherapy protocol sessions will be held virtually (by forming groups of five people in the Whats App application and providing training in the form of video calls, sending short animation videos, uploading brochures and homework forms in the application Whats App and getting feedback from subjects) will be provided.The content of this program is as follows:The first session: Getting to know and using the abilities: knowing the top 5 abilities and using them in daily life. Getting to know the training course, enjoyment of life, happiness and cheerfulness and its role in a good life and ways to achieve a satisfying life, measuring the level of cheerfulness, depression and enjoyment of the participants' life. Personal capabilities, getting to know the classification of capabilities and moral virtues, using personal capabilities in a new way.Second session: Appreciation meeting: Appreciation of people who have done important work for you. Emphasis on good memories, moving towards creating appropriate interpersonal communication, training in the technique of appreciation and gratitude (thankful letter and meeting).The third session: Active/constructive response: Active and constructive response to the good news of others. Familiarity with positive social relationships, the role of positive relationships in a happy life, training and application of the technique of constructive and active response.Fourth session: Counting the blessings: paying attention to the small blessings of life and remembering three of them every day. Examining the effects of writing three blessings or good things in life, intention and meaning in life.The fifth session: sense of taste: enjoying the small pleasures of life, such as drinking a cup of tea, getting to know positive emotions, the role of positive emotions in happiness and joy, using the mention of blessings and good things in life as positive things.The sixth session: maintaining the therapeutic effects: receiving feedback from the subjects and providing exercises for use in the future. Feedback from the training course, holding a celebration, coordinating the way to follow up.Tools: use of PowerPoint, animation, short film and brochure.نماد «مورد تأیید انجمن».نماد «مورد تأیید انجمن»
Category
Lifestyle
2
Description
Control group: 35 menopausal women who have passed 12 months since their last menstrual period and meet the conditions to enter the study.No special intervention is done on them and they receive routine care from the Comprehensive Health Center and an educational text will be prepared and provided to them at the end of the study.نماد «مورد تأیید انجمن»
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected comprehensive health centers of Urmia
Full name of responsible person
Sara Mehrpooya
Street address
Delgosha Quay, Atai Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 6060
Email
saramehrpooya1359@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
the headquarters of the University of Buildings,Resalat Blvd Vice President of Research and Technology,the end of the emergency room,
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
research@umsu.ac.ir
Web page address
https://research.umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Sara Mehrpooya
Position
Senior student of midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Emergency room,Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
saramehrpooya1359@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Soheila Rabiepoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Emergency room,Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
soheila80@yahoo.com
Web page address
https://umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sara Mehrpooya
Position
Senior student of midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Emergency room,Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
saramehrpooya1359@gmail.com
Web page address
https://umsu.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
in the form of an article
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions and research students in this field
Under which criteria data/document could be used
Using the results in articles and comparing them in new works is not prohibited
From where data/document is obtainable
saramehrpooya1359@gmail.com
What processes are involved for a request to access data/document
After the applicant's request via email, the necessary checks will be done and the information will be available shortly after the confirmation.