Clinical Trial Protocol Iranian Registry of Clinical Trials
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Clinical Trial Protocol Iranian Registry of Clinical Trials 01 Oct 2021 Promoting health literacy about self-care in pregnancy and its effect on self-care in pregnant women referring to Pakdasht Comprehensive health service centers Protocol summary an educational film. Main outcome variables Study aim health literacy and self-care Aim of the study is determination of the effect of intervention to promote health literacy about self-care in General information pregnancy on self-care in pregnant women referring to Pakdasht Comprehensive health service centers. Reason for update Design Acronym Data collection tools are two researcher made IRCT registration information questionnaire about health literacy and self-care in IRCT registration number: IRCT2017030415650N8 pregnancy. Registration date: 2017-06-01, 1396/03/11 Settings and conduct Registration timing: registered_while_recruiting In first stage , questionnaires will be filled in two groups in Pakdasht Comprehensive health service centers. Then Last update: 2018-07-21, 1397/04/30 an intervention will be planned based on analysis of the Update count: 1 data . Intervention consists 4 educational sessions. Registration date Duration of each session is 45 minutes and teaching 2017-06-01, 1396/03/11 methods will be lecture, group discussion, question and answer, counseling, demonstration. educational Registrant information materials are a leaf let and an educational film. Name Intervention will be done only in case group in Pakdasht Mahnaz Solhi Comprehensive health service centers. In second stage, Name of organization / entity one months and three months after intervention, Iran University of Medical Sciences questionnaire will be filled again. Data will be analyzed Country and compared in two groups. Iran (Islamic Republic of) Participants/Inclusion and exclusion criteria Phone pregnant women referring to Pakdasht Comprehensive +98 21 8877 9928 health service centers. inclusion criteria are covered by Email address the studied women at Pakdasht Comprehensive health [email protected] service centers, pregnant weren't be sick and gestational age of 12 weeks to 24 weeks, and the exclusion criteria Recruitment status are moving and leaving the coverage of the center and Recruitment complete Mother's illness. Funding source Intervention groups Vice-chancellor for research and Technology, Iran Two group ( control and case). Intervention consists 4 University of medical Sciences educational sessions. Duration of each session is 45 minutes and teaching methods will be lecture, group Expected recruitment start date discussion, question and answer, counseling, 2017-05-05, 1396/02/15 demonstration. educational materials are a leaf let and Expected recruitment end date 1 2018-05-05, 1397/02/15 1 Actual recruitment start date Ethics committee empty Name of ethics committee Actual recruitment end date empty Ethics Committee of Iran University of Medical Trial completion date Sciences empty Street address Ethics Committee, Vice-chancellor for research and Scientific title Technology, Iran University of Medical Sciences, near Promoting health literacy about self-care in pregnancy Milad Hospital, Hemmat highway and its effect on self-care in pregnant women referring to City Pakdasht Comprehensive health service centers Tehran Province Public title Tehran Health promotion about self-care in pregnancy Postal code Purpose 1449614535 Prevention Approval date Inclusion/Exclusion criteria 2017-04-22, 1396/02/02 Inclusion criteria: Ethics committee reference number En inclusion criteria: The women are covered by IR.IUMS.REC. 1395.95-04-27-30279 Pakdasht Comprehensive health service centers. Mothers weren't ill and their pregnancy age were12 to 24 weeks. Exclusion criteria: Health conditions studied Moved up and be in out of coverage of Pakdasht Comprehensive health service centers Mother's illness pregnancy age were12 to 24 weeks 1 Age Description of health condition studied No age limit Self-care in pregnancy Gender ICD-10 code Female ICD-10 code description Phase N/A Primary outcomes Groups that have been masked Participant 1 Sample size Description Target sample size: 80 Self-care in pregnancy Randomization (investigator's opinion) Timepoint Randomized Before intervention, one and two months after education Randomization description Method of measurement Out of 10 Pakdasht comprehensive health centers, 2 Resercher made questionnaire centers were randomly selected. Then, from the two centers, a center was assigned to the control group and Secondary outcomes another to the intervention group by randomly. Blinding (investigator's opinion) empty Not blinded Blinding description Intervention groups articipants in the study were kept blind about dividing in control and case groups 1 Placebo Not used Description Assignment Intervention in case group: It consists 4 educational Parallel sessions. Duration of each session is 45 minutes and Other design features teaching methods will be lecture, group discussion, question and answer, counseling, demonstration. Secondary Ids educational materials are a leaf let and an educational film. Intervention will be done in Pakdasht empty Comprehensive health service centers. Category Ethics committees Prevention 2 2 Yes Title of funding source Description Vice-chancellor for research and Technology, Iran Intervention in control group: No intervention will be University of medical Sciences done in control group. Proportion provided by this source Category 100 N/A Public or private sector Public Recruitment centers Domestic or foreign origin Domestic Category of foreign source of funding 1 empty Recruitment center Country of origin Name of recruitment center Type of organization providing the funding Pakdasht Comprehensive health service centers Academic Full name of responsible person Khadijeh Abbasi Person responsible for general inquiries Street address Contact ﺧﯿﺎﺑﺎن ﺷﻬﯿﺪ ﻣﻄﻬﺮی City Name of organization / entity Pakdasht Department of Health Services, School of Health, Iran Province University of Medical Sciences Tehran Full name of responsible person Postal code Mahnaz Solhi 3391938561 Position Phone PhD of Health Education/ Associate Prof. +98 21 3602 3110 Latest degree Fax Ph.D. +98 21 3602 1051 Other areas of specialty/work Email Street address [email protected] School of Health, Iran University of Medical Sciences, near Milad Hospital, Hemmat highway Sponsors / Funding sources City Tehran Province 1 Tehran Sponsor Postal code Name of organization / entity 1449614535 Vice-chancellor for research and Technology, Iran Phone University of medical Sciences +98 21 8670 4758 Full name of responsible person Fax Dr. syyed Ali Javad Moosavi Email Street address [email protected] Vice-chancellor for research and Technology, Iran Web page address University of Medical Sciences, near Milad Hospital, Hemmat highway Person responsible for scientific City inquiries Tehran Province Contact Tehran Name of organization / entity Postal code Department of Health Services, School of Health, Iran 1449614535 University of Medical Sciences Phone Full name of responsible person +98 21 8670 2503 Mahnaz Solhi Fax Position +98 21 8862 2707 PhD of Health Education/ Associate Prof. Email Latest degree [email protected] Ph.D. Grant name Other areas of specialty/work Grant code / Reference number Health Promotion Is the source of funding the same sponsor Street address organization/entity? School of Health, Iran University of Medical Sciences, 3 near Milad Hospital, Hemmat highway City City Tehran Tehran Province Province Tehran Tehran Postal code Postal code 1449614535 1449614535 Phone Phone +98 21 8670 4758 +98 21 8670 4758 Fax Fax Email +98 21 8862 2707 [email protected] Email Web page address [email protected] Web page address Sharing plan Person responsible for updating data Deidentified Individual Participant Data Set (IPD) No - There is not a plan to make this available Contact Justification/reason for indecision/not sharing IPD Name of organization / entity Due to the confidentiality of the data file of participants Department of Health Services, School of Health, Iran in the study as one of the ethical considerations University of Medical Sciences Study Protocol Full name of responsible person No - There is not a plan to make this available Mahnaz Solhi Statistical Analysis Plan Position No - There is not a plan to make this available PhD of Health Education/ Associate Prof. Informed Consent Form Latest degree No - There is not a plan to make this available Ph.D. Clinical Study Report Other areas of specialty/work Not applicable Health Promotion Analytic Code Street address No - There is not a plan to make this available School of Health, Iran University of Medical Sciences, Data Dictionary near Milad Hospital, Hemmat highway Not applicable 4.