Determining the effectiveness of cognitive-behavioral training on emotional dyslexia and distress tolerance in infertile women undergoing treatment in Ahvaz.
Design
As a cluster method, among the 4 infertility centers in the city, 2 centers were randomly selected, and among the infertile women under treatment, those who met the criteria for entering the study were selected in the desired number (70).
Settings and conduct
In the first step, the pre-test was performed, and then in the second step, the training protocol (9 training sessions) was performed for the experimental group, but no training was provided for the control group. In the third step, immediately after the completion of the last training session (ninth session), after the implementation test, the findings and data obtained from this research were analyzed and the researcher finally discussed and concluded.
Participants/Inclusion and exclusion criteria
Criteria for entering the research:
1- Willingness to cooperate and participate in research (satisfaction to participate in research)
2- The patient has been treated with intrauterine insemination (IUI) at least once
3- Infertility confirmed by a doctor
4- Vigilance and awareness of the disease
5_ Proficiency in Persian language
6- Lack of simultaneous attendance in cognitive-behavioral educational programs
7_ The ability to communicate
8_ Being treated by the patient
Exclusion criteria from the research:
1- Non-cooperation and not doing the homework of each meeting
2- Unwillingness to continue participating in research
3- Taking interventional drugs
4- Incomplete completion of the questionnaire
5_ Pregnancy
6_ Physical diseases
7- Over 40 years old
Intervention groups
Subjects were randomly assigned to two experimental and control groups of 35 people in each group
Main outcome variables
Cognitive behavioral training, emotional dyslexia and distress tolerance
General information
Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number:IRCT20240112060692N1
Registration date:2024-01-18, 1402/10/28
Registration timing:retrospective
Last update:2024-01-18, 1402/10/28
Update count:0
Registration date
2024-01-18, 1402/10/28
Registrant information
Name
Kosar Pourdastan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 4457
Email address
kosarpour0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-05-23, 1402/03/02
Actual recruitment start date
2023-05-15, 1402/02/25
Actual recruitment end date
2023-05-25, 1402/03/04
Trial completion date
2023-07-21, 1402/04/30
Scientific title
The effectiveness of cognitive-behavioral training on emotional dyslexia and distress tolerance in infertile women undergoing treatment
Public title
The effectiveness of cognitive-behavioral training on emotional dyslexia and distress tolerance in infertile women undergoing treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate and participate in research (satisfaction to participate in research)
The patient has been treated with intrauterine insemination (IUI) at least once
Infertility disease confirmed by a doctor
Awareness and awareness of the disease
Proficiency in Persian language
Lack of simultaneous attendance in cognitive-behavioral educational programs
Ability to communicate
The patient is being treated
Exclusion criteria:
Non-cooperation and not doing the homework of each session
Unwillingness to continue participating in research
Use of interventional drugs
Incomplete completion of the questionnaire
pregnancy
physical diseases
Over 40 years old
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In order to carry out the research, the infertility centers of Ahvaz city were referred to and 2 centers were randomly selected from among the 4 infertility centers in the city, and among the infertile women under treatment, there were people who met the entry criteria for the research. 70 people were selected.
The working method was that the subjects were randomly placed in two test groups and 35 people in each control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Kazeroon branch
Street address
No. 73, 9 West Street, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
618395191
Approval date
2023-05-14, 1402/02/24
Ethics committee reference number
IR.IAU.KAU.REC.1402.045
Health conditions studied
1
Description of health condition studied
Cognitive-behavioral training on emotional dyslexia and distress tolerance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of cognitive-behavioral training on ataxia in the Toronto ataxia questionnaire and distress tolerance in Simmons and Gaher's distress tolerance questionnaire.
Timepoint
Before starting the cognitive-behavioral training, ataxia was 22.57 and distress tolerance was 48.09, and after the intervention, ataxia decreased to 48.03 and distress tolerance increased to 34.53.
Method of measurement
Alexithymia was measured with the Toronto Alexithymia Questionnaire and Distress Tolerance was measured with the Simmons and Gaher Distress Tolerance Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: At first, a pre-test was taken from the group, and then the cognitive-behavioral training protocol was taught to 35 subjects in 9 sessions of 60-90 minutes, and at the end of the last session, a post-test was taken from the subjects.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Department of Imam Khomeini Hospital
Full name of responsible person
Kosar Pourdastan
Street address
No. 73, Padadshahr West 9th Street, Moheb Building, Unit 2
City
Ahvaz
Province
Khouzestan
Postal code
6183895191
Phone
+98 916 527 8071
Email
kosarpour0@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Personal budget
Full name of responsible person
Kasar Pourdastan
Street address
No. 73, West 9th Street, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6183895191
Phone
+98 916 527 8071
Email
kosarpour0@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
0
Proportion provided by this source
1
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Shiraz branch
Full name of responsible person
kosar pourdastan
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 73, West 9th Street, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
Kosar Pourdastan, [1
Phone
+98 61 3553 4457
Email
kosarpour0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Shiraz branch
Full name of responsible person
Ali Nasery
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shiraz - Heng intersection towards Banafshe intersection, next to Esteghlal 14 alley. Sepehr building. third floor. Unit 3
City
Shiraz
Province
Fars
Postal code
6183895191
Phone
+98 61 3553 4457
Email
dr.alinaseri@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kosar Pourdastan
Position
Graduated from Islamic Azad University
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 73, 9 West Street, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6183895191
Phone
+98 61 3553 4457
Fax
Email
kosarpour0@gmail.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
Due to the confidentiality of the subjects' information and maintaining the condition of confidentiality, we are not allowed to publish the participants' information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
There is no permission to publish the information of the clients
When the data will become available and for how long
never
To whom data/document is available
The person responsible for the research
Under which criteria data/document could be used
Due to the principle of confidentiality, it is not possible at all
From where data/document is obtainable
Send an email to the person responsible for the research kosarpour0@gmail.com
What processes are involved for a request to access data/document
Send an email to the person responsible for the research kosarpour0@gmail.com