Clinical Trial Protocol Iranian Registry of Clinical Trials
Total Page：16
File Type：pdf, Size：1020Kb
Clinical Trial Protocol Iranian Registry of Clinical Trials 06 Oct 2021 The Effect of Group Counseling Based Problem-Solving Advice on the Experience of Domestic Violence in Pregnant Women Protocol summary Last update: 2019-10-31, 1398/08/09 Update count: 0 Study aim Registration date Determining the Effect of Problem-Based Group 2019-10-31, 1398/08/09 Counseling on the Experience of Domestic Violence in Registrant information Pregnant Mothers Name Design Masoumeh Alamshahi The clinical trial study included a control group. Each Name of organization / entity group consisted of 40 pregnant women exposed to Country violence who were randomly assigned to a non-placebo- Iran (Islamic Republic of) controlled draw Phone Settings and conduct +98 28 3422 8606 This study was performed at the Buin Zahra Urban Email address Integrated Health Service Centers. After reviewing the [email protected] mothers' electronic records, mothers who meet the Recruitment status inclusion criteria will be selected and the cts2 Recruitment complete questionnaire will be completed. The mothers were then Funding source randomly assigned into two groups of 40 each. The intervention group consisted of 6 45-minute group counseling sessions per week. Expected recruitment start date Participants/Inclusion and exclusion criteria 2019-08-06, 1398/05/15 18 to 35 years with 10 to 30 weeks gestation; no mental Expected recruitment end date illness; no infertility treatment; no stressful couple life 2020-01-20, 1398/10/30 Actual recruitment start date Intervention groups empty Hold 6 45-minute group counseling sessions for Actual recruitment end date intervention group one session per week, if the control empty group results are effective, they will receive similar Trial completion date interventions empty Main outcome variables Violence Scientific title The Effect of Group Counseling Based Problem-Solving Advice on the Experience of Domestic Violence in General information Pregnant Women Reason for update Public title Acronym The Effect of Group Counseling Based Problem-Solving IRCT registration information Advice on the Experience of Domestic Violence in IRCT registration number: IRCT20191022045202N1 Pregnant Women Registration date: 2019-10-31, 1398/08/09 Purpose Registration timing: registered_while_recruiting Prevention 1 Inclusion/Exclusion criteria Ethics committees Inclusion criteria: Individual and his / her spouse do not have confirmed psychiatric illness (self-report and electronic file of 1 spouse and pregnant woman) Failure to receive Ethics committee psychological treatment for the past six months in the Name of ethics committee individual and his or her spouse By age 10 to 30 weeks Ethics Committee of Qazvin University of Medical when enrolling in the study. Diagnosis of Violence Sciences According to the Conflict Resolution Tactics Street address Questionnaire in Pregnant Women in Each Area of the Shahid Bahonar Blvd. Questionnaire Willing to participate in the study. City Exclusion criteria: Qazvin Stressful event in the life of each couple, such as the Province death of a first-degree family member, or an accident Qazvin that caused physical or mental injury in the past three Postal code months Infertility and receiving pre-pregnancy infertility 3419915315 treatments Consumption of drugs, tobacco and alcohol in Approval date the person and his or her spouse Couples on the verge of 2019-05-08, 1398/02/18 separation Ethics committee reference number Age IR.QUMS.REC.1398.027 From 18 years old to 35 years old Gender Health conditions studied Female Phase 1 N/A Description of health condition studied Groups that have been masked Violence against pregnant women No information ICD-10 code Sample size ICD-10 code description Target sample size: 80 Randomization (investigator's opinion) Primary outcomes Randomized Randomization description A multi-stage cluster method will be used to select the 1 research units in this study. In the first phase, all Buin Description Zahra comprehensive health services centers (5 Buen Violence against pregnant women Zahra comprehensive health services centers, Seqsabad, Timepoint Dunesfahan, Shawl and Ardagh) will be studied after Before study, immediately and three months after study referring to comprehensive municipal health services Method of measurement centers and reviewing all pregnant mothers' electronic Conflict Resolution Tactics Questionnaire cts2 records and Their spouses are selected mothers who meet the inclusion criteria. Demographic questionnaires Secondary outcomes and CTS2 questionnaires will be completed for all eligible mothers who meet the inclusion criteria;If the number of empty identified individuals at risk of violence at this stage exceeds the population needed for our study, Intervention groups approximately 80 of these individuals will be selected using a random number table. Individuals were divided 1 into intervention and control groups. Blinding (investigator's opinion) Description Not blinded Intervention group: six 45-minute group counseling Blinding description sessions once a week Placebo Category Not used N/A Assignment Parallel Recruitment centers Other design features 1 Secondary Ids Recruitment center empty Name of recruitment center 2 Boin Zahra Centers Qazvin University of Medical Sciences Full name of responsible person Full name of responsible person Masoumeh Alamshahi Amir Peymani Street address Street address Western Moallem Str Shahid Bahonar Blvd. City City Boin Zahra Qazvin Province Province Qazvin Qazvin Postal code Postal code 3461969863 3419915315 Phone Phone +98 28 3422 8602 +98 28 3333 6001 Email Email [email protected] [email protected] Web page address 2 Grant name Recruitment center Grant code / Reference number Name of recruitment center Is the source of funding the same sponsor Ardagh Centers organization/entity? Full name of responsible person Yes Masoumeh Alamshahi Title of funding source Street address Qazvin University of Medical Sciences EMAM Str Proportion provided by this source City 100 Ardagh Public or private sector Province Public Qazvin Domestic or foreign origin Postal code Domestic 3461969863 Category of foreign source of funding Phone empty +98 28 3422 8602 Country of origin Email Type of organization providing the funding [email protected] Academic 3 Person responsible for general inquiries Recruitment center Name of recruitment center Contact Shal Centers Name of organization / entity Full name of responsible person Qazvin University of Medical Sciences Masoumeh Alamshahi Full name of responsible person Street address Masoumeh Alamshahi Emam Str Position City student Shal Latest degree Province Bachelor Qazvin Other areas of specialty/work Postal code Midwifery 3461969863 Street address Phone No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street +98 28 3422 8602 City Email Qazvin [email protected] Province Qazvin Sponsors / Funding sources Postal code 4361969863 Phone 1 +98 28 3422 8602 Sponsor Email Name of organization / entity [email protected] 3 Person responsible for scientific Province Qazvin inquiries Postal code Contact 4361969863 Name of organization / entity Phone Qazvin University of Medical Sciences +98 28 3422 8602 Full name of responsible person Email Masoumeh Alamshahi [email protected] Position student Sharing plan Latest degree Bachelor Deidentified Individual Participant Data Set (IPD) Other areas of specialty/work No - There is not a plan to make this available Midwifery Justification/reason for indecision/not sharing IPD Street address No more information No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street Study Protocol City Yes - There is a plan to make this available Qazvin Statistical Analysis Plan Province No - There is not a plan to make this available Qazvin Informed Consent Form Postal code No - There is not a plan to make this available 4361969863 Clinical Study Report Phone No - There is not a plan to make this available +98 28 3422 8602 Analytic Code Email No - There is not a plan to make this available [email protected] Data Dictionary No - There is not a plan to make this available Person responsible for updating data Title and more details about the data/document Study Protocol Contact When the data will become available and for how Name of organization / entity long Qazvin University of Medical Sciences End of study Full name of responsible person To whom data/document is available Masoumeh Alamshahi Personnel in scientific educational institutions Position Under which criteria data/document could be used student To use the results of the study as sources for evaluation Latest degree and Formulate similar next interventions Bachelor From where data/document is obtainable Other areas of specialty/work Masoumeh [email protected] Midwifery What processes are involved for a request to access Street address data/document No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street Send email requesting data Send the data within one City month to the requestor Qazvin Comments 4.