The effect of spirituality education on the happiness of postmenopausal
Design
After registering eligible individuals, they will be divided into two groups of control and intervention through a random number table.
Settings and conduct
By registering with the selected center, we will register the eligible individuals. First, the questionnaires are completed in two groups separately. Then the spiritual training sessions will be held at the Seven-Cenar Health home during 6 sessions of 90 minutes (number of sessions per week will be agreed upon by participants). Immediately and one month after the completion of the Oxford Happiness Inventory sessions, both groups will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: postmenopausal (at least one year after the last menstruation) and reading and writing literacy.
Non-compliance criteria include: having a known mental disorder and mourning experience in the first six months of a relative
Intervention groups
The intervention group will be the group who will receive the training program. Finally, in order to comply with ethical issues, upon completion of the training, the outline will be held in two sessions for the control group.
Main outcome variables
changes of happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110425006284N14
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spirituality education on the happiness of postmenopausal women
Public title
The effect of spirituality education on the happiness of postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is between 50 and 65 years old.The age range is between 50 and 65 years old.
Postmenopausal, at least one year after their last menstruation.
Having reading and writing skills
Exclusion criteria:
Known as a mental illness.
In the first-degree relatives during the past six months, they have a mourning experience.
Age
From 50 years old to 65 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 allocation of samples to the intervention and control groups will be random and simple using random numbers. In fact, the selection of the research environment will be made available and the allocation of samples will be done in two groups of intervention and control by simple random method.
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 Tehran university of Medical Sciences Faculty of Nursing and Midwifery and Rehab
Street address
Tehran Province, Tehran, District 6, Nosrat St
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.TUMS.FNM.REC.1397.033
Health conditions studied
1
Description of health condition studied
Happiness, Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
happiness
Timepoint
At the beginning of the study (before the intervention), immediately after the end of the session and one month after the end of the intervention
Method of measurement
Oxford Happiness Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the demographic information and happiness questionnaire is completed. Then, training sessions on Spirituality will focus on topics such as self-awareness, trust and recourse, patience, forgiveness and sugar during 6 sessions of 90 minutes (number of sessions per week will be agreed upon by participants). Immediately and one month after the completion of the Oxford Happiness Inventory sessions, it will be completed again.
Category
Other
2
Description
Control group: Complete the Oxford Happiness Questionnaire and Demographic Information Questionnaire before the intervention and provide routine care by health personnel, then complete the Oxford Happiness Questionnaire immediately and one month after the end of the intervention. Finally, in order to comply with ethical issues, the outline will be held in two sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabad Health Center and its related sites، Affiliated to Tehran University of Medical Sciences
Full name of responsible person
Sima. aghay
Street address
Akbar Abad Center of society of Health, Mahboob mojaz St, Khosh St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1355774896
Phone
+98 21 5570 5972
Email
aghaei397@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraeean
Street address
5th floor, Central building of Tehran University of Medical sciences, edge of Qods Av, Keshavarz blvd, Tehran
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3686
Fax
+98 21 8163 3047
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Modarres
Position
Phd Medical education
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Tehran, Tohid square,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 4471 7330
Fax
+98 21 4471 7330
Email
modarres@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Modares Maryam
Position
Phd Medical education
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Tohid square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
modarres@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima aghay
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 7, No33., Golzarand St., Safdari Ave., South navab St ., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1355774896
Phone
+98 21 5570 5972
Email
aghaei397@gmail.com
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
Because the results of the statistical survey of the data will be published.
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is 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 text of the letter of consent form
When the data will become available and for how long
17 July 2018
To whom data/document is available
All students
Under which criteria data/document could be used
Being a student
From where data/document is obtainable
Send an email to aghaei397@gmail.com.
What processes are involved for a request to access data/document
Send student card image to email aghaei397@gmail.com