Protocol summary

Study aim
Determining the Effect of an Intervention on Increasing the empowerment of Health Care in Married Women of Reproductive Age Referring to Health Care Centers affiliated to Tehran University of Medical Sciences.
Design
This is a randomized controlled trials. The population of the study is 484 married women of reproductive age, aged 15-49 years old. They are referred to health centers in southern Tehran to receive health care. The method of sampling in each center is done randomly. Intervention for one month and 5 sessions will be held for 30 to 45 minutes as group training. Subsequently, the questionnaire will be completed six months after the intervention for both interventions and comparisons.
Settings and conduct
Health centers in south Tehran, selected centers are randomly selected.
Participants/Inclusion and exclusion criteria
The criteria for entering The study are marriage, being in reproductive age (15-49), consent to participate in the study, women who have literacy and nationality as Iranian. Exit criteria The study participants are reluctant to continue cooperation and absence more than 2 sessions in the training sessions that will be held for 5 sessions for the intervention group
Intervention groups
The intervention group of married women of reproductive age(15-49) referred to Southern health centers with written consent and willingness to participate in studying and receiving educational interventions to increase the ability to receive health care.Control group: Married women of reproductive age referring to the same centers that do not receive any educational intervention
Main outcome variables
empowerment to receive health care, Behavioral intention, attitude towards behavior, normative beliefs and perceived behavior control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151208025431N6
Registration date: 2018-08-11, 1397/05/20
Registration timing: prospective

Last update: 2018-08-11, 1397/05/20
Update count: 0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Elham Shakibazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3210
Email address
shakib@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an intervention on health care empowerment among women in reproductive age referring to health centers affiliated to Tehran University of Medical Sciences: Application of the Theory of Planned Behavior
Public title
The Effect of Intervention on Increasing the empowerment health care in married women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women referring to health centers in the south At the age of fertility (age 49-15) Satisfaction to participate in the study Women who are literate read and write Their nationality is Iranian.
Exclusion criteria:
The unwillingness of the subjects under study to continue cooperation Absence of more than 2 sessions in the training sessions, with 5 sessions for the intervention group.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 484
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization
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
Street address
Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.TUMS.SPH.REC.1397.017

Health conditions studied

1

Description of health condition studied
Empowerment to receive health care in women of reproductive age
ICD-10 code
Z76.1
ICD-10 code description
Health supervision and care of foundling

Primary outcomes

1

Description
Behavioral intention
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

2

Description
Attitude towards the behavior
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

3

Description
Behavioral beliefs
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

4

Description
Outcom evaluation
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

5

Description
Subjective norm
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

6

Description
Normative beliefs
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

7

Description
motivation to comply
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

8

Description
Perceived behavioral control
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

9

Description
Control Beliefs
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

10

Description
Perceived Power
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior

Secondary outcomes

1

Description
Empowerment health care in two dimensions: feeling and importance
Timepoint
Before the intervention and 6 months after the intervention
Method of measurement
Standard (Health Care Empowerment Questionnaire)

Intervention groups

1

Description
Intervention group: Educational interventions to increase the empowerment to receive health care in married women of reproductive age (aged 15-49) with the application of the theory of planned behavior and the needs assessment that was done prior to the beginning of the study and the empowerment to receive health care in women of reproductive age before The intervention will be measured 6 months after the intervention.
Category
Behavior

2

Description
Control group: In the control group, intervention is not performed and only after completing the study for observance of the ethics of all the teaching aids will be provided to this group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
South Tehran Health Centers
Full name of responsible person
Dr. Ghayumzadeh
Street address
No. 2, Alley, Shahid Abbas Shafiee,Vesal SHirazi Ave, Engelab Ave
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 6695 0069
Email
Gayumzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeiyan
Street address
Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
name@domian.com
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 Saboury
Position
Student Master
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 77624517
Email
msaboury@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Shakibazeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
shakibazadeh@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Saboury
Position
MS Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 7762 4517
Email
msaboury@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
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