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Educational lifestyle intervention (health promotion model-based) concern to vaginit in reproductive-age women : provide an appropriate model

Protocol summary

Summary
This study is an intervention survey. Objectives of this study is effectiveness determination of educational intervention (Health Promotion Model-based) on lifestyle related to vaginitis and relapse of disease in reproductive age women with vaginitis . Questionnaire is the instrument for gathering data. This questionnaire has designed according literature review, qualitative interviews and expert’s panel. After Psychometric (validity -reliability (pre-test is distributing in both intervention and control groups .These questionnaires will be completed by researcher through interview and observation. Sampling procedure is a two-stage clustered sampling. Ten health centers in five regions of North, South, East, West and center of Kermanshah will be chosen randomly. Each center is closed to another will be chosen randomly as a control center and another center as the intervention. The sample size is 340 and 170 sample in each group will examined randomly. Inclusion criteria are: reproductive age (10 to 49 years old), marital status, vaginitis diagnosed, intention to participate in the study, settlement in Kermanshah, no risk of certain diseases (cancer, diabetes, deficiency of the immune systems). After completing the pre-test in both of two groups, intervention will be performed as face to face education, group training and presenting pamphlet. Both of two groups will receive standard treatment in health center. After 4 to 8 months, post-test questionnaire will be completed in both of them. Impact of this intervention on health promoting lifestyle regards vaginitis and relapse of this disease will be measured and results will be analyzed and interpret.

General information

Acronym
non acronym
IRCT registration information
IRCT registration number: IRCT2015012620817N1
Registration date: 2015-06-24, 1394/04/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-24, 1394/04/03
Registrant information
Name
Roxana Parsapour
Name of organization / entity
Tehran University of Medica Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 1403
Email address
roxanaarya@gmail.com
Recruitment status
Recruitment complete
Funding source
personal finance and chancellor for education in Tehran University of Medical Science
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Educational lifestyle intervention (health promotion model-based) concern to vaginit in reproductive-age women : provide an appropriate model
Public title
Effect of educational lifestyle intervention (health promotion model-based) concern to vaginit in reproductive-age women : provide an appropriate model
Purpose
Prevention
Inclusion/Exclusion criteria
reproductive age( 15-49 years old ; being married; diagnosed vagini in health center during sampling; tendency to participation in research ;living in kermanshah city; having no specific disorder or disease such as cancer,diabetes,immune deficiency disease
Age
From 10 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 340
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
non

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Tehran University of Medical Sciences
Street address
Central Building Tehran University of Medical Sciences, Ghods Street, Keshavarz Bulvar, Tehran, Iran
City
Tehran
Postal code
14155-6446
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
9021108004-133603

Health conditions studied

1

Description of health condition studied
vaginit
ICD-10 code
N77.1*
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere

Primary outcomes

1

Description
lifestyle related to vaginitis
Timepoint
4-8 mounth
Method of measurement
interview.observation

Secondary outcomes

1

Description
relapse
Timepoint
4-8mounth
Method of measurement
observation.examination

Intervention groups

1

Description
educational intervention include: face to face education for 170 case, group education in 20 secession for 20 minutes, provide pamphlet, phone contact and responsibility
Category
Lifestyle

2

Description
Control group doesn't get any intervention. They receive just routine drug treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Health Center
Full name of responsible person
Roxana Parsapour
Street address
Health Promotion Department, Floor 4, Health Faculty, Tehran University of Medical Science, Poorsina Street, KeshavarzBulva, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Chancellor for Education of Tehran Medical University
Full name of responsible person
Mohammad Jalili
Street address
Number701, Central Building,Tehran Medical University,Ghods Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Chancellor for Education of Tehran Medical University
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, Health Faculty
Full name of responsible person
Fereshteh Majlesi
Position
Professor
Other areas of specialty/work
Street address
Health Faculty of Tehran Medical University, Poorsina, Keshavarz Bulvar, Tehran
City
Tehran
Postal code
141556446
Phone
+98 21 8898 9134
Fax
+98 21 8898 9129
Email
dr_f_majlessi@yahoo.com
Web page address
non

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Faculty of Tehran Medical University
Full name of responsible person
Fereshteh Majlesi
Position
Professor
Other areas of specialty/work
Street address
Health Faculty of Tehran Medical University, Poorsina, Keshavarz Bulvar, Tehran
City
Tehran
Postal code
141556446
Phone
+98 21 8898 9134
Fax
+98 21 8898 9129
Email
dr_f_majlessi@yahoo.com
Web page address
ندارد

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roxana Parsapour
Position
PhD Student of Health Promotion
Other areas of specialty/work
Street address
Health Promotion Department, Floor 4, Health Faculty, Tehran University of Medical Sciences, Poorsina Street, Keshavarz Bulvar, Tehran, Iran
City
Tehran
Postal code
141556446
Phone
+98 21 8895 1403
Fax
+98 21 8898 9129
Email
roxanaarya@gmail.com
Web page address
ندارم

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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