Protocol summary
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Study aim
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Evaluating the effect of Multimedia mental health selfcare program in infertile women based on cyberspace on users mental health
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Design
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A clinical trial with a control group, randomized on 90 patients (45 patients in intervention group and 45 patients in control group), was used to randomize the order (RAND) in Excel software.
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Settings and conduct
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Place of Research: Fatemeh Al-Zahra Infertility Training and Treatment Center, Babol city.
The participants are placed in the intervention and control groups with easy and continuous sampling and random allocation. Before and one month after the intervention, both groups will complete electronic questionnaires.
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Participants/Inclusion and exclusion criteria
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All infertile women eligible to enter the study, referred to Fatemeh Al-Zahra Infertility Center in Babol
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Intervention groups
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The intervention group is infertile women who refer to Fatemeh Al-Zahra Infertility Center in Babol city. In addition to receiving routine infertility care, they will have access to the content of their multimedia mental health care program through the link sent .
The control group is infertile women who refer to Fatemeh Al-Zahra Infertility Center in Babol, who will receive only routine infertility care.
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Main outcome variables
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Mental health (anxiety, depression, infertility-related stress, perceived stress, psychological well-being), satisfaction
General information
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Reason for update
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Updating information related to the person responsible for scientific accountability of the study,
Updating information related to the name of the responsible person at the sampling site,
Changing the sampling start date due to limited access to some messengers.
Modifying some entry criteria due to limited access to some messengers.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210526051410N1
Registration date:
2022-11-06, 1401/08/15
Registration timing:
prospective
Last update:
2023-01-28, 1401/11/08
Update count:
1
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Registration date
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2022-11-06, 1401/08/15
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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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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-07-22, 1402/04/31
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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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Evaluating the impact of a multi media mental health self-care program based on cyber Space on the mental health of infertile women
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Public title
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The impact of a multi media mental health self-care program based on cyber Space on the mental health of infertile women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having personal satisfaction
Primary infertility diagnosed in the case
Primary infertility diagnosed in first marriage
In infertility treatment
Age group 20 years and older
Having an Android smartphone
Installation of persian messengers on mobile phone
Adequate knowledge in the use of social networks (persian messengers )
Internet access
Iranian nationality
Infertility duration one year and above
Being literate in reading and writing
Exclusion criteria:
History or current history of severe psychological disorders based on the participant's report such as major depression, bipolar depression and suicidal ideation
Substance abuse or psychotropic drugs
History of first-degree relatives dying or losing a job in the past 6 months
Having an adopted child
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Age
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From 20 years old to 48 years old
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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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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this research, randomization into two intervention groups (45 people) and control (45 people) will be done by simple randomization method. For randomization, the function of random numbers in Excel software will be used.
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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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2021-04-27, 1400/02/07
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1400.011
Health conditions studied
1
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Description of health condition studied
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Mental health
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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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Mental health of infertile women
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Timepoint
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Before and one month after the intervention
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Method of measurement
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Psychological Well-Being, Beck Depression, Spielberger Anxiety, Perceived Stress and Infertility Stress Questionnaires
Secondary outcomes
1
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Description
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Satisfaction with using a multimedia mental health self-care program
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Timepoint
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After the intervention
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Method of measurement
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Researcher-made questionnaire of satisfaction with education
Intervention groups
1
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Description
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Intervention group: Infertile women are referred to Fatemeh Al-Zahra Infertility Center in Babol. In addition to receiving routine infertility care, through the link sent by the researcher to the content of the multimedia mental health self-care program uploaded on the Fatemeh Infertility Center website Al-Zahra will have access to the city of Babel and will use their mental health self-care behaviors for a specified period of time.
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Category
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Prevention
2
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Description
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Control group: Infertile women referred to Fatemeh Al-Zahra Infertility Center in Babol city will receive only routine infertility care during the intervention and are the same as the intervention group in terms of inclusion and exclusion criteria.
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Category
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Prevention
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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Shahid Beheshti 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