The purpose of this study is to determine the effectiveness of cognitive-behavioral counseling based on body image on the general health of infertile women.
Design
No intervention is performed on the control group and they are placed on the waiting list.
Settings and conduct
24 qualified people will be selected and will be randomly assigned to one of two intervention and control groups. For the intervention group, 8 one-hour sessions per week for cognitive-behavioral counseling will be conducted by infertility research and treatment center of ACECR in Ahvaz.
In this research, from the eight-step treatment to the weight-loss copper, which has eight steps to change the negative body image of people, and in each step, approved cognitive-behavioral methods are used to improve this body image.
Participants/Inclusion and exclusion criteria
Age 18-45 years- Cycle education-Having a history of infertility for at least two years-Diagnosing disorders in public health based on questionnaires;A woman getting pregnant - missing more than two sessions - mental problems
Intervention groups
The intervention group receives eight sessions of cognitive behavioral therapy. The duration of each session is 60 minutes and has a specific structure.No intervention is performed on the control group and they are placed on the waiting list.
The effectiveness of cognitive behavioral therapy (based on body image) on the general health of infertile women
Public title
The effectiveness of cognitive behavioral therapy (based on body image) on the general health of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years
Cycle education
Having a history of infertility for at least two years
Diagnosing disorders in public health based on questionnaires
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was simple random assignment. The randomization unit was the individual. A random sequence was created through a web-based numeric sequencer (http://www.randomizer.org). In order to hide the random allocation, the person involved in the randomization process was separate from other researchers to reduce possible bias.
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 Islamic Azad University Behbahan Branch
Street address
بهبهان، بلوار امیر کبیر ، خیابان شهید بیانی
City
Behbahan
Province
Khouzestan
Postal code
6361713198
Approval date
2023-06-02, 1402/03/12
Ethics committee reference number
IR.IAU.BEHBAHAN.REC.1402.001
Health conditions studied
1
Description of health condition studied
general health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
General Health
Timepoint
Before the intervention - immediately after the intervention - one month after the intervention
Method of measurement
General health questionnaire(GHQ)
2
Description
Mental image of the body
Timepoint
Before the intervention - immediately after the intervention - one month after the intervention
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
General health questionnaire(GHQ)
2
Description
anxiety
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
General health questionnaire(GHQ)
3
Description
Social function
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
General health questionnaire(GHQ)
4
Description
physical symptoms
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
General health questionnaire(GHQ)
5
Description
physical satisfaction
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
General health questionnaire(GHQ)
Intervention groups
1
Description
Intervention group: The intervention group receives 8 sessions of cognitive behavioral therapy based on body image. The duration of each session is 60 minutes and has a specific structur.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility research and treatment center of ACECR Khouzestan
Full name of responsible person
Zohreh Ahmady
Street address
Pardis St., Gladis Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
8656435766
Phone
+98 916 982 5673
Email
info@ahz-ivf.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
shahrooei
Street address
Shahid Bayani Ave.,AmirKabir Blvd.,Behbahan City
City
Behbahan
Province
Khouzestan
Postal code
6361713198
Phone
+98 61 5287 0105
Fax
Email
info@behu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available