Determining the effect of cognitive-behavioral group counseling on genital self-image and sexual self-esteem of women applying for genital cosmetic surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 70 people undergoing genital cosmetic surgery. For randomization, rand function of Excel software was used. Randomization unit: individual
How to make a random sequence: block randomization with a block size of four (randomization of replaced blocks)
How people enter the random sequence: according to the sequence created by the Random Allocation Software
Settings and conduct
Study implementation platform:
Neyshabor Gynecologists' Office . The method of gathering information will be through filling out questionnaires.. The intervention will be in the form of counseling sessions, during 8 90-minute sessions twice a week in the form of presentation of PowerPoint, questions and answers, and dynamic relationship for the people in the intervention group. Attendance at a counseling center will be done. . The number of women present in the meetings will be 11-12 people (three groups).
Participants/Inclusion and exclusion criteria
Inclusion criteria:. Don't be pregnant.
Age between 18 and 50 years and performing genital cosmetic surgery
Having no medical indication for genital cosmetic surgery
Exclusion criteria:
Participation in more than two sessions of non-consultation
Intervention groups
Intervention group: women applying for genital cosmetic surgeries who will receive 8 sessions of cognitive-behavioral counseling in person.
Control group: will not receive counseling.
Main outcome variables
The change of the total score of sexual self-esteem and genital self-image score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230426058001N1
Registration date:2023-06-21, 1402/03/31
Registration timing:retrospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Hamide Mollanorouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 2611
Email address
mollanorouzih981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of cognetive-behavioral group counseling on the sexual self-esteem and genital self-image in the women seeking genital cosmetic surgry
Public title
the effect of counseling on the sexual self-esteem and genital self-image
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian
Not pregnant
Not menopause
There is no medical indication for genital cosmetic surgery according to the gynecologist's opinion.
have written informed consent to participate in the research
Be between 18 and 50 years old
Apply for genital cosmetic surgery
Have at least a cycle certificate and a smartphone
Don't have severe stress, anxiety and depression
Do not participate in cognitive behavioral counseling or training classes at the same time
There should be no addiction to alcohol and drugs in the woman and her husband
Unfortunate incidents have not happened to him in the last 6 months.
Exclusion criteria:
Failure to participate in more than two counseling sessions
Occurrence of accidents during the study
Incomplete completion of questionnaires (response rate less than 90%)
Age
From 18 years old to 50 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
A randomized clinical trial with a pre-test and post-test plan will be conducted on 70 women applying for genital cosmetic surgery (before and after cosmetic surgery) referring to private offices and clinics and beauty centers in Neishabur city. After obtaining permission from the ethics committee of the university and receiving a letter of introduction from the research vice-chancellor of the Mashhad Midwifery Nursing School, the researcher will conduct sampling by visiting beauty clinics and gynecologists' offices daily. Sampling will be done among the eligible applicants for genital cosmetic surgery by the available method.
Then the objectives and method of the research will be explained to them by the researcher. If they are willing and meet the entry criteria, written consent will be obtained from them to enter the research. Then they will be randomly divided into intervention and control groups.
Randomization Unit: Individual
How to make a random sequence: Permuted block randomization with a block size of four
How people enter the random sequence: according to the sequence created by the Random Allocation Software
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 Mashhad University of Medical Sciences
Street address
University St., Ibn Sina St., Dr. Crossroad, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUMS.REC.1401.400
Health conditions studied
1
Description of health condition studied
Healthy people willing to undergo unnecessary cosmetic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing the sexual self-esteem score.
Timepoint
Before the start of the intervention and one month after the end of the intervention (counseling sessions)
Method of measurement
Zina and Schwarz sexual self-esteem questionnaire - shortened form.(SSEI-W-SF).
2
Description
Changing the genital self-image score
Timepoint
Before the start of the intervention and one month after the end of the intervention (counseling sessions)
Method of measurement
Genital self-image questionnaire.(FGSIS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, group cognitive-behavioral counseling is held face-to-face in 8 sessions of 90 minutes twice a week. The number of women present in the meetings will be 11-12 people (three groups). The content of the sessions includes: introduction, explanation of the work method and the type of counseling and the research goal of people's cognitive reconstruction, including the process of identifying and evaluating ineffective and unhelpful spontaneous thoughts, as well as ineffective coping behaviors. In the field of self-image and body image and sexual self-esteem, identifying and evaluating cognitive distortions, realistically looking at the individual valuation system, identifying strengths and weaknesses and correcting them. At the end of each
Category
N/A
2
Description
Control group: Women applying for genital cosmetic surgery who will not receive any advice.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologists' office in Neishabur city and beauty clinics
Full name of responsible person
Hamide sadat Mollanorouzi
Street address
Attar street.Attar 9
City
Neyshabour
Province
Razavi Khorasan
Postal code
9313763866
Phone
+98 51 4322 0900
Email
mollanorouzih981@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Street address
Razavi Khorasan, University St., Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
MirzakhaniK@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Sadat Mollanorouzi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
15 Vali Asr Street, Taban Building, Plate 85, 6th Floor.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318743745
Phone
+98 51 4263 4350
Email
mollanorouzih981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
Email
MirzakhaniK@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Sadat Mollanorouzi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
15 Vali Asr St., Taban Building. No. 85. Sham floor
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318743745
Phone
+98 51 4263 4350
Email
mollanorouzih981@mums.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