Protocol summary
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Study aim
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Aim of the study is determination of the effect of intervention to promote health literacy about self-care in pregnancy on self-care in pregnant women referring to Pakdasht Comprehensive health service centers.
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Design
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Data collection tools are two researcher made questionnaire about health literacy and self-care in pregnancy.
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Settings and conduct
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In first stage , questionnaires will be filled in two groups in Pakdasht Comprehensive health service centers. Then an intervention will be planned based on analysis of the data . Intervention consists 4 educational sessions. Duration of each session is 45 minutes and teaching methods will be lecture, group discussion, question and answer, counseling, demonstration. educational materials are a leaf let and an educational film. Intervention will be done only in case group in Pakdasht Comprehensive health service centers. In second stage, one months and three months after intervention, questionnaire will be filled again. Data will be analyzed and compared in two groups.
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Participants/Inclusion and exclusion criteria
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pregnant women referring to Pakdasht Comprehensive health service centers. inclusion criteria are covered by the studied women at Pakdasht Comprehensive health service centers, pregnant weren't be sick and gestational age of 12 weeks to 24 weeks, and the exclusion criteria are moving and leaving the coverage of the center and Mother's illness.
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Intervention groups
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Two group ( control and case).
Intervention consists 4 educational sessions. Duration of each session is 45 minutes and teaching methods will be lecture, group discussion, question and answer, counseling, demonstration. educational materials are a leaf let and an educational film.
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Main outcome variables
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health literacy and self-care
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017030415650N8
Registration date:
2017-06-01, 1396/03/11
Registration timing:
registered_while_recruiting
Last update:
2018-07-21, 1397/04/30
Update count:
1
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Registration date
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2017-06-01, 1396/03/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice-chancellor for research and Technology, Iran University of medical Sciences
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Expected recruitment start date
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2017-05-05, 1396/02/15
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Expected recruitment end date
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2018-05-05, 1397/02/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Promoting health literacy about self-care in pregnancy and its effect on self-care in pregnant women referring to Pakdasht Comprehensive health service centers
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Public title
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Health promotion about self-care in pregnancy
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
En inclusion criteria: The women are covered by Pakdasht Comprehensive health service centers. Mothers weren't ill and their pregnancy age were12 to 24 weeks.
Exclusion criteria:
Moved up and be in out of coverage of Pakdasht Comprehensive health service centers
Mother's illness
pregnancy age were12 to 24 weeks
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Out of 10 Pakdasht comprehensive health centers, 2 centers were randomly selected. Then, from the two centers, a center was assigned to the control group and another to the intervention group by randomly.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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articipants in the study were kept blind about dividing in control and case groups
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-04-22, 1396/02/02
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Ethics committee reference number
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IR.IUMS.REC. 1395.95-04-27-30279
Health conditions studied
1
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Description of health condition studied
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Self-care in pregnancy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Self-care in pregnancy
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Timepoint
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Before intervention, one and two months after education
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Method of measurement
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Resercher made questionnaire
Intervention groups
1
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Description
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Intervention in case group: It consists 4 educational sessions. Duration of each session is 45 minutes and teaching methods will be lecture, group discussion, question and answer, counseling, demonstration. educational materials are a leaf let and an educational film. Intervention will be done in Pakdasht Comprehensive health service centers.
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Category
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Prevention
2
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Description
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Intervention in control group: No intervention will be done in control group.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice-chancellor for research and Technology, Iran University of medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to the confidentiality of the data file of participants in the study as one of the ethical considerations
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable