Determining the effect of group counseling on stress and gender role attitudes in infertile women
Design
This Clinical practice has two groups: control group and, intervention group that participants are divided by using random numbers table in two groups of 35.
Settings and conduct
Selected Infertility Centers of Alborz Province, which include 2 Infertility Centers (Roish and Ebne Sina (Kamali Branch))
Participants/Inclusion and exclusion criteria
Medical diagnosis for infertility; Iranian nationality; fluent in Persian; Infertility with female factor; at least the reading and writing skills; having a score higher than 16 from the Newton questionnaire; age18_44 years old. Exclusion criteria: having psychiatric issues; according to one's own words Infertility with male factor; not attending 5 at least 3 sessions of counseling sessions.
Intervention groups
In the intervention group, infertile women with entry criteria are referred to the selected centers of infertility in Alborez province, who will receive weekly counseling in 5 sessions (90 minutes). And the control group will not receive any advice
Main outcome variables
Stress, gender role attitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020719N6
Registration date:2018-04-14, 1397/01/25
Registration timing:registered_while_recruiting
Last update:2018-04-14, 1397/01/25
Update count:0
Registration date
2018-04-14, 1397/01/25
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-03, 1396/11/14
Expected recruitment end date
2018-04-18, 1397/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling on stress and gender role attitude of infertile women
Public title
The effect of counseling on stress and female behaviors of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have medical diagnosis based on infertility
Iranian nationality
Fluent in Persian
Infertility with female factor
At least the reading and writing skills
Age between 18_44 years old
Exclusion criteria:
Having psychiatric issues, according to one's own words
Infertility with male factor
Not attending 5 at least 3 sessions of counseling sessions
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random numbers 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
Vice-Chancellor for Research in Alborz University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, Alborz University of Medical Sciences, above Taleghani Square, Taleghani Square, Karaj, Alborz, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-01-19, 1396/10/29
Ethics committee reference number
IR.ABZUMS.REC.1396.161
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Stress
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
Newton Infertility Stress Questionnaire
2
Description
Gender Roll Attitude
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
Homami`s Gender Role Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 7 non-Bargain women are grouped together in five groups of seven, and a two-hour counseling session for 5 sessions (90 minutes), delivered in a speech, question and answer file, according to the British Infertility Advice Protocol, gender role attitude, rights and health Fertility will be advised and followed up by phone call. To avoid facing the control and intervention group, it is attempted to arrange classrooms on different days of the week and in coordination with contributors through telephone conversations. Session 1: The purpose of the study, the presentation of information on infertility, the emotional consequences of infertility, how to create them and their relationship with infertility, methods and treatment protocol, drug side effects, success rate, how to use drugs and their side effects Second session: how to donate gametes and Embryo, fertility storage, uterus rental, talking about sexual problems, identifying women's thoughts and centralized feelings about infertility by discussing group discussions and expressing their opinions and exercising relaxation 9. (1. Mind-to-Muscle Technique 2. Technique Muscle to mind) Session 3: Helping to adapt to conditions, stress and sexual performance, exercises of lawmaking with reflection of the mind The focus is on women's respiration, based on the BIRITISH protocol and relaxation practice. Fourth part: 10, the expression of women's rights and discussion of other roles of women in life and practice of relaxation. The fifth session: the summing up of past sessions and the way Stress control (advise on exercise, especially hiking, starting a new pastime, meditating, and eating a stress relieving diet) and relaxation exercises. The sessions will be validated by the faculty members of the midwifery department at the university.
Category
Behavior
2
Description
Control group: In the control group, no advice is given to individuals, and at the end of the workbook, the contents of the stress control methods are given to both groups (control and intervention).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Roivish Infertility Centers and Ibn Sina Kamali Branch
Full name of responsible person
Dr. Sara Eesmaelzadeh Saeh
Street address
Infertility Center, Azimi Hospital, Golestan, 18, and Avicenna Infertility Center Kamali Branch: Shahid Square, Seyyed Alshohada St.
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
esmaelzadeh1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research in Alborz University of Medical Sciences
Full name of responsible person
Mohamad Nourisepeher
Street address
Research Deputy of Alborz University of Medical Sciences, Azimiyeh-Alborz Square, Iran
City
KARAJ
Province
Alborz
Postal code
0098
Phone
+98 26 3255 8920
Email
z.ehsan90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research in Alborz University of Medical Sciences
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
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran
City
karaj
Province
Alborz
Postal code
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
دانشگاه علوم پزشکی البرز
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran
City
alborz
Province
Alborz
Postal code
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh saieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran
City
karaj
Province
Alborz
Postal code
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant data can be shared after unidentifiable
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Public
Under which criteria data/document could be used
For use in studies allowed.
From where data/document is obtainable
z.ehsan90@gmail.com
What processes are involved for a request to access data/document
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items.