Comparison of the Effectiveness of Metacognitive Counseling in a Virtual and In-Face Surveillance on the Anxiety and Metabolism of Women with Abortion History
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181120041707N1
Registration date:2019-05-23, 1398/03/02
Registration timing:retrospective
Last update:2019-05-23, 1398/03/02
Update count:1
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Mina Ghiyasi Shahmabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3235 8692
Email address
www.m.ghiasi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-01, 1397/10/11
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Comparison of Metacognitive Counseling in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History
Public title
Effectiveness Comparison of Metacognitive Counseling in Virtual and Face To Face method on the Anxiety and Meta-worry of Women with Abortion History
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Bahonar Square- Central building of Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.SSU.REC.1397.091
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people with a Beck Anxiety Scale is above 15.
Timepoint
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
Method of measurement
Beck Anxiety Inventory
2
Description
Percentage of people whose score of questionnaire is above 17.
Timepoint
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
Method of measurement
metaworry questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
N/A
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Jafar Sadeg Hospital
Full name of responsible person
Mina GhiyasiShahmabadi
Street address
Imam Jafar Sadiq Hospital, Basij Boulevard, Basij Street
City
Meybod
Province
Yazd
Postal code
8961977138
Phone
+98 35 3235 1200
Fax
+98 35 3235 1206
Email
sadeghhosp@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
South Shahid Sadoughi St,Bahonar Square,Third floor university building - Deputy of Research and Technology
City
Yazd
Province
Yazd
Postal code
8961977138
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?