Determining the effect of cognitive-behavioral counseling on mental health of infertile women through virtual education
Design
An intervention of randomized controlled trials in two groups of controlled, double-blind, pre-test pre-test post-test research design.
Settings and conduct
After obtaining a license from Islamic Azad University, Falavarjan Branch, and providing a research environment and observing ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who were confirmed by infertility by a gynecologist. And consent will be obtained from them. When specifying the samples, they will be given personalized mobile phone numbers and educational materials through telegrams in a textual form as well as in vises. Anxiety, depression and quality of life will be measured before and after intervention.
Participants/Inclusion and exclusion criteria
Age 20-45 years old; being Muslim; Iranian nationality; having at least elementary education; not having a degree in psychology and counseling; lack of drug addiction; not having severe and well-known physical and mental illness.
Intervention groups
After obtaining a license from Islamic Azad University, Falavarjan Branch, and providing a research environment and observing ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who were confirmed by infertility by a gynecologist. And consent will be obtained from them. When specifying the samples, they will be given personalized mobile phone numbers and educational materials through telegrams in a textual form as well as in vises. Anxiety, depression and quality of life will be measured before and after intervention
Main outcome variables
Anxiety; depression; quality of life and marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131110015349N3
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Maryam Allahdadian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7140
Email address
allahdadian@iaufala.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the effect of cognitive – behavioral counseling on anxiety, depression, quality of life and marital satisfaction through virtual education
Public title
Exploring the effect of cognitive – behavioral counseling on anxiety, depression, quality of life and marital satisfaction through virtual education
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20-45 years old
Being Muslim
Nationality Iranian
Having at least elementary education -
Not having a degree in psychology and counseling
No drug addiction
Not having severe and well-known physical and mental illness
Exclusion criteria:
Unwillingness to participate in research
Patients who used anti-depressant and anti-inflammatory drugs during the study
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
People who go to the Infertility Center are being given one-on-one appointment
Blinding (investigator's opinion)
Single blinded
Blinding description
Contributors were kept blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Najaf Abad
Street address
Islamic Azad University of Najaf Abadad, University Blvd.
City
Najaf Abad
Province
Isfehan
Postal code
8514143131
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1397.018
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Depression
ICD-10 code
F31.10
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features, unspecified
3
Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Marital Satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression
Timepoint
Before and one month after the intervention
Method of measurement
questionnaire
2
Description
Quality of Life
Timepoint
Before and one month after the intervention
Method of measurement
questionnaire
3
Description
Marital Satisfaction
Timepoint
Before and one month after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, after obtaining a license from Islamic Azad University, Falavarjan Branch, and presenting to the research environment and ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who confirmed their infertility by obstetrician. At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When specifying samples, they are taken from their personal mobile phone number or email, and educational materials are provided via telegram or e-mail, as well as in plain text. Individual questions will also be answered by telegram or by message or telephone call. Anxiety, depression and quality of life will be measured before and after intervention. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication
Category
Rehabilitation
2
Description
Control group: Control group: In this study, after obtaining permission from the Islamic Azad University of Falavarjan Branch and presenting to the research environment and observing ethical considerations, the case group was enrolled in a study of 30 patients with a control group of 30 who were afflicted with infertility by obstetrician and obstetrician. . At the beginning of the work, for each sample, the title of the study and the method of work will be described and the consent form will be completed in the form of the consent form. When identifying the samples, depression anxiety, marital satisfaction and quality of life questionnaires are completed. Then, after completing one additional month, the questionnaires are completed again and the score for anxiety, depression and quality of life will be measured before and after each other. It should be noted that none of these women will use drugs due to depression and anxiety at the time of the research. Made In addition, patients will be contacted every 2 weeks during the study and will be assured of the lack of use of the medication. And in the event of a problem, due to ethical considerations, they were advised and excluded from intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologist and infertility clinic
Full name of responsible person
Maryam Allahdadian
Street address
University Blvd., Basij Boulevard,
City
Esfahan
Province
Isfehan
Postal code
1558415
Phone
+98 31 3742 0135
Email
maryamallahdadian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Street address
Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan
City
Esfahan
Province
Isfehan
Postal code
155 84515
Phone
+98 31 3742 0135
Email
maryamallahdadian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan
City
Esfahan
Province
Isfehan
Postal code
15584515
Phone
+98 31 3742 6614
Email
maryamallahdadian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryamallahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan
City
Isfahan
Province
Isfehan
Postal code
15584515
Phone
+98 31 3742 6614
Email
Maryamallahdadian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, University Blvd., Basij Boulevard, Falavarjan
City
Isfahan
Province
Isfehan
Postal code
15584515
Phone
+98 31 3742 6614
Email
Maryamallahdadian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"No more information".
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
All people
Under which criteria data/document could be used
Use links with the sourc
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document