The purpose of this study was to design and evaluation of an educational intervention in the field of happiness, inner strength and mental health of women then proposed a proper model.
Inclusion criteria: middle-aged women referred to health houses of the municipalities who do not suffer from mental illness and mood disorders.
Exclusion criteria: mood disorders, anxiety and depression and other disorders that lead to a lack of appropriate participation and more than two sessions absence during educational sessions.
The study population was women aged 60-40 years referred to health houses of Tehran and the sample size was 200 people.
This study is a randomized clinical trial and case-control; include the educational programs based on model, and carried out to determine the effect of interventional education based on fitted model to enhance the mental health of women referred to health houses in Tehran during two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052522404N1
Registration date:2016-11-08, 1395/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Samaneh Zanjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 6351
Email address
s_zanjani@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, International Campus
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of an interventional education model on happiness, inner strength and mental health of women; Appropriate framework
Public title
interventional education model on happiness, inner strength and mental health of women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The middle-aged women referred to municipality health house; Age 40-60 years; The alertness and reluctant to express their inner feelings about the concept studied; The lack of diagnosed psychiatric and mood disorders and cognitive disorders; The lack of exposure to a particular case or the accident which led to has been the psychological trauma in the past 6 months; Desire and satisfaction to participate in the study; Having certain and available address and phone number for follow-up. Exclusion criteria: Items such as mood disorders, anxiety, depression and other disorders that lead to a lack of appropriate participation; Having a psychiatric history; Using drugs for psychiatric disorders; The loss of a close person during the study; Unwillingness to participate voluntarily in the study by filling out the questionnaire incomplete; More than two sessions Absence during the training sessions.
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences and Health Services
Street address
School of Public Health and Institute of Health Research, Health Education and promotion department, Poorsina Ave, 16 Azar Ave
City
Tehran
Postal code
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.tum.rec.1394.133811
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
Z00.4
ICD-10 code description
General psychiatric examination, not elsewhere classified
Primary outcomes
1
Description
Happiness
Timepoint
Before the intervention, immediately after the end of intervention and six months after intervention
Method of measurement
questionnaire
2
Description
inner strength
Timepoint
Before the intervention, immediately after the end of intervention and six months after intervention
Method of measurement
questionnaire
3
Description
Mental Well-being
Timepoint
Before the intervention, immediately after the end of intervention and six months after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Case Group: Educational programs in the field of mental health promotion by lecture, group discussion and problem solving methods, Receive training package included pamphlets and CD
Category
Other
2
Description
Control Group: Receive training package included pamphlets and CD after the post-test
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghezel Ghale Health House
Full name of responsible person
Amineh Parandlo
Street address
Ghezel Ghale Health House, 15th Street (Shahid Azizi), Jahanara Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-President for Research Affairs, International Campus, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Hadian
Street address
Office of Vice-President for Research Affairs, Number 124 , Baradaran-e-Mozaffar St.,Dameshgh St., Vali-e Asr Ave., Tehran 3439123900, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-President for Research Affairs, International Campus, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health and Institute of Health Research, Health Education and promotion department, Poorsina Ave, 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 8895 5888
Fax
Email
sadeghir@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Davood Shojaizadeh
Position
Professor
Other areas of specialty/work
Street address
School of Public Health and Institute of Health Research, Health Education and promotion department, Poorsina Ave, 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 4293 3211
Fax
Email
Shojaei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Zanjani
Position
Health education MS
Other areas of specialty/work
Street address
School of Public Health and Institute of Health Research, Health Education and promotion department, Poorsina Ave, 16 Azar Ave
City
Tehran
Postal code
Phone
00
Fax
Email
zanjani.samaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)