Protocol summary
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Study aim
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Comparison of the Effectiveness of Metacognitive Counseling in a Virtual and In-Face Surveillance on the Anxiety and Metabolism of Women with Abortion History
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Design
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Clinical trials with control group, with parallel groups, blind, randomized
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Settings and conduct
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Samples are selected from among women with a history of abortion that are referred to the clinic and women's ward of Imam Jafar Sadegh Hospital, who are eligible to enter the study. The subjects are divided into two virtual counseling and in-person counseling sessions. Then, both virtual intervention and face-to-face interviews are grouped under a group counseling protocol during eight 90-minute counseling sessions on meta-cognitive therapy advised by supervisors, psychologist, counselor, and observer. Each research unit is said to have 50 percent chance of being assigned to a virtual or personal group.
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Participants/Inclusion and exclusion criteria
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Aged over 18؛Legitimate Pregnancy؛Married and permanent marriage؛Iranian ethnicity؛Both groups have virtual intervention and mobile presenceBoth groups have Internet and mobile Internet literacy and / or IOS؛Interest in attending counseling sessions؛Having a commitment to carry out the relevant؛assignments (attending all meetings or at least 6 sessions and doing more than 75% of the assignments to the consultant's appointment)؛Pregnancy asked؛Not having a history of abortion
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Intervention groups
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The virtual intervention and the presence of both are grouped under a group counseling protocol during eight 90-minute counseling sessions on meta-cognitive therapy. Each research unit is said to have 50 percent chance of being assigned to a virtual or personal group.
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Main outcome variables
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Using the results of the study in the health sector to improve and reduce the complications of anxiety and hypertension in people with it if effective interventions are effective.
General information
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Reason for update
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Enter the end date of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181120041707N1
Registration date:
2019-05-23, 1398/03/02
Registration timing:
prospective
Last update:
2020-09-21, 1399/06/31
Update count:
1
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Registration date
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2019-05-23, 1398/03/02
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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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2019-01-01, 1397/10/11
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Expected recruitment end date
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2019-01-20, 1397/10/30
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Actual recruitment start date
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2019-05-26, 1398/03/05
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Actual recruitment end date
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2019-06-26, 1398/04/05
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Trial completion date
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2019-09-22, 1398/06/31
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Scientific title
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Effectiveness Comparison of Metacognitive Counseling in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History
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Public title
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Effectiveness Comparison of Metacognitive Counseling in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age is over 18 years old
Pregnancy is legitimate
Married and have permanent marriage
Have Iranian ethnicity
Both groups have virtual intervention and mobile presence
Both groups have Internet and mobile Internet literacy and / or IOS
Interested in attending counseling sessions
Of the obligation to carry out the relevant assignments (attending all meetings or at least 6 sessions and carrying out more than 75% of the assignments to the consultant's appointment)
Pregnancy is wanted
Have a history of abortion
Exclusion criteria:
According to the research unit, there is a history of alcohol and tobacco use and drugs such as antidepressants
Simultaneously participate in the same study
There is a problem that causes an increase in sadness, anxiety and depression, such as close relatives, etc. in the last 2 months
The systemic, genetic, or psychiatric diseases are afflicted by a research unit itself
Be pregnant
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Age
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From 18 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:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Women with a history of abortion who are eligible for inclusion in the study are divided into two groups of virtual counseling (20 in two groups of ten) and face-to-face counseling (20 in two groups of ten) using a randomized computer table
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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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2018-11-10, 1397/08/19
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Ethics committee reference number
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IR.SSU.REC.1397.091
Health conditions studied
1
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Description of health condition studied
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Abortion
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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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The percentage of people with a Beck Anxiety Scale is above 15.
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Timepoint
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Determine and compare the mean of anxiety score before the intervention, the end of the eighth week of intervention and the 12th week of intervention
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Method of measurement
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Beck Anxiety Inventory
2
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Description
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Percentage of people whose score of questionnaire is above 17.
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Timepoint
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Determination and comparison of the mean scores of anesthesia before the onset of intervention, the end of the eighth week of intervention and the 12th week of intervention
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Method of measurement
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metaworry questionnaires
Intervention groups
1
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Description
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Intervention group: Virtual Consultation.Virtual consultancy is provided in multimedia and attractive format and one day a week by virtual method through installing one of the authorized Persian messaging software and having the ability to secure private space suitable for mobile phone research units, and from them You will be asked to submit your questions online and get help from the researcher. It is worth mentioning that for the purpose of providing Internet chat, the package is provided weekly and free of charge to the virtual intervention group by the researcher until the end of the study period. For this purpose, the mobile number of the research units will be designed by the researcher after receiving informed consent and the group will be designed to respond to the researcher. Regarding how to coordinate with research units, such as attending a group chat at the scheduled time, homework reminders, or the desire to have a private chat after the end of the chat group, the necessary information is provided by the researcher.
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Category
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N/A
2
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Description
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Intervention group: In-person counseling.Individuals under the group counseling protocol are included in eight 90-minute counseling sessions on meta-cognitive therapy advised by supervisors, psychologist, counselor, and observer.
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Category
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N/A
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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Yazd 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable