Protocol summary
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Study aim
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Determining the effectiveness of midwifery counseling with a motivational interview approach on men's participation in pre-pregnancy care
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Design
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Randomized clinical trial of parallel type with two arms, without blinding, Restricted randomization of block randomization type with blocks of four, allocation sequence is generated by the software.
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Settings and conduct
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A clinical trial with two control and intervention arms, available sampling method, in the comprehensive health center of Sorkheh city and Semnan Health Center , in order to collect information before assigning people to the control and intervention groups, from the demographic questionnaire and the researcher-made questionnaire of male participation in Women's pre-pregnancy care and the standard questionnaire to evaluate men's knowledge, attitude and performance regarding reproductive health before having children, which will be used by the couple, and the stages of change questionnaire which will be completed by men.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age under 50 years for men and 15-45 years for women and intention to have children in the next year; Exclusion criteria: wife being pregnant.
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Intervention groups
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Five sessions of motivational interview for couples, one session per week and each session in 45-60 minutes for the intervention group. At the end of the study, a training session with the content of pre-pregnancy health and childbearing for the control group.
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Main outcome variables
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Couple's knowledge and attitude towards men's prenatal care; Men's participation in women's pre-pregnancy care including wife's companionship, wife's health recommendations, wife's financial and emotional support and man's awareness of women's problems and health in pre-pregnancy 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:
IRCT20231214060361N1
Registration date:
2024-01-06, 1402/10/16
Registration timing:
prospective
Last update:
2025-09-10, 1404/06/19
Update count:
1
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Registration date
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2024-01-06, 1402/10/16
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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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Expected recruitment start date
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2024-03-20, 1403/01/01
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Expected recruitment end date
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2024-05-21, 1403/03/01
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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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Evaluation of the effectiveness of counseling on midwifery with a motivational interview approach on men's participation in preconception care
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Public title
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Evaluation of the effectiveness of motivational interview approach on men's participation in preconception care
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Literacy for reading and writing
Being Iranian
Age below 50 years for men and 15-45 years for women
Intend to have children in the next year
Consent and cooperation to participate in the study
Exclusion criteria:
Staff and students of the University of Medical Sciences
Having a history of infertility treatment (according to the person's statement)
Having a known chronic disease
Wife being pregnant
Participation in similar programs
Difficulty in communicating such as blindness and deafness and any cognitive impairment
Poor health of the child or previous children
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Age
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From 15 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We will use the restricted randomization method of the block randomization type. . The size of all the blocks is equal and we will use 4 blocks in this experiment. We will have 6 blocks in this order (BABA, BBAA, AABB, BAAB, ABBA, ABAB) and the blocks will be numbered. A will be the test group and B will be considered as the control group. In blocks of 4, two allocations to the intervention group and two allocations to the control group are considered.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2023-11-28, 1402/09/07
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Ethics committee reference number
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IR.SHMU.REC.1402.138
Health conditions studied
1
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Description of health condition studied
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Preconception care
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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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Couple's knowledge and attitude towards men's preconception care
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Timepoint
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Before the start of the intervention, immediately after the intervention and 3 months after the intervention
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Method of measurement
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Questionnaire to evaluate the knowledge, attitude and performance of married men regarding pre-pregnancy care.
2
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Description
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Men's involvement in women's prenatal care
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Timepoint
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Before the start of the intervention, immediately after the intervention and 3 months after the intervention
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Method of measurement
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Questionnaire to evaluate the knowledge, attitude and performance of married men regarding pre-pregnancy care
Intervention groups
1
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Description
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Intervention group: Five sessions of motivational interview for couples, one session per week and each session lasts 45-60 minutes
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Category
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Behavior
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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Shahroud 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available