Protocol summary
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Study aim
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Determining the Impact of Mental Health Self -care Pattern Counseling on Anxiety and Depression of Women with Pregnancy Diabetes
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Design
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Clinical trial with control group, with parallel groups, randomized, on 84 patients. Random Allocation Software was used for randomization.
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Settings and conduct
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Pregnant women with gestational diabetes with a gestational age of 24-30 weeks, referring to the gynecology and perinatal clinic of Amirul Mominin Educational and Therapeutic Center (AS) of Semnan University of Medical Sciences, provided they meet the entry criteria and consent to enter the study, were selected as available. be. Then they complete the hospital anxiety and depression questionnaire. Women with anxiety and depression scores between 8 and 14 are included in the study. First, the self-care questionnaires of mental health, self-efficacy of diabetic patients and health-promoting behaviors in pregnancy are completed before the intervention, and then they are randomly assigned to two intervention and control groups.
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Participants/Inclusion and exclusion criteria
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Pregnancy of 24 to 30 weeks and a singleton, gestational diabetes, at least elementary literacy, access to a smartphone and informed consent. The conditions of non-entry include drug addiction, history or currently suffering from medical or mental illness, studying in medical sciences. Speech and hearing disorders, an unfortunate incident in the last 6 months, complications related to pregnancy
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Intervention groups
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In addition to receiving routine pregnancy care, the intervention group receives mental health self-care counseling during 6 sessions of 45 minutes, once a week.
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Main outcome variables
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Change in anxiety and depression scores
General information
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Reason for update
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Allocation to study groups and increase sampling time
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230130057274N1
Registration date:
2023-03-25, 1402/01/05
Registration timing:
prospective
Last update:
2024-08-06, 1403/05/16
Update count:
3
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Registration date
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2023-03-25, 1402/01/05
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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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2023-04-09, 1402/01/20
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Expected recruitment end date
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2024-03-20, 1403/01/01
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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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The effect of self-care model counseling based on mental health on anxiety and depression of women with gestational diabetes
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Public title
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The effect of self-care model counseling on gestational diabetes
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
pregnant women 24 to 30 weeks with single pregnancy
Iranian and resident of Semnan
Diagnosing gestational diabetes by a doctor based on the criteria for diagnosing gestational diabetes of the Safe Motherhood National Program
Having the minimum elementary literacy
Access to the smartphone
Earn anxiety and depression score between 8-14 based on anxiety and hospital depression questionnair
Informed consent
Exclusion criteria:
Drug addiction
History or current suffering from other medical or physical illness and known mental illness
Studying in medical sciences
Speech and hearing disorders that prevent communication with the researcher
The occurrence of an unfortunate incident in the last 6 months that has led to tension
Occurrence of complications related to pregnancy such as premature birth and preeclampsia
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Age
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From 20 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:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Subjects are randomly divided into two groups after applying the inclusion and exclusion criteria in the form of random allocation using the alternative block method. The size of the blocks is 4 and using the statistical software, 4 blocks will be produced 21 times. Considering that the sampling is done in one center, a sample list of 84 items will be produced. Using this randomly generated list, the participants are assigned to two groups of 42 people.
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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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Other
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Other design features
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84 people are invited to study in two groups of 42 (42 for the intervention group and 42 for the control group).
Ethics committees
1
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Ethics committee
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Approval date
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2023-01-22, 1401/11/02
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1401.221
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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ICD-10 code
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XV
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ICD-10 code description
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XV Pregnancy, childbirth and the puerperium
Primary outcomes
1
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Description
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Change in anxiety scores
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Timepoint
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Before the intervention, after the intervention, one month after the intervention, and six weeks after delivery
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Method of measurement
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Hospital Anxiety and Depression Scale
2
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Description
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Change in depression scores
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Timepoint
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Before the intervention, after the intervention, one month after the intervention, and six weeks after delivery
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Method of measurement
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Hospital Anxiety and Depression Scale
Secondary outcomes
1
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Description
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Changing the score of health promotion behaviors
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Timepoint
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Before the intervention, after the intervention, one month after the intervention, and six weeks after delivery
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Method of measurement
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Prenatal health behavior scale
2
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Description
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Changing the mental health self-care score
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Timepoint
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Before the intervention, after the intervention, one month after the intervention, and six weeks after delivery
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Method of measurement
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Mental health self-care questionnaire
3
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Description
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Changing the self-efficacy score
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Timepoint
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Before the intervention, after the intervention, one month after the intervention, and six weeks after delivery
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Method of measurement
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Self-efficacy scale Gestational diabetes
Intervention groups
1
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Description
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Intervention group: This group of pregnant women in the 24th to 30th weeks of pregnancy, in addition to receiving routine pregnancy care, receive mental health self-care counseling during 6 sessions of 45 minutes, once a week. The content of counseling sessions includes the first session: Conceptualization of the mental self-care model, familiarity with diabetes, and principles of disease control, the second session: self-awareness of one's condition and illness, the third session: physical self-care, the fourth session: identifying negative thoughts and emotions caused by diabetes and cognitive reconstruction, the fifth session: self-care against stress, the sixth session: reconstruction of communication.
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Category
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Treatment - Other
2
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Description
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Control group: This group of pregnant women in the 24th to 30th weeks of pregnancy only receive routine pregnancy care and do not receive mental health self-care counseling.
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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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Babol 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