Comparison of the effectiveness of Sexual Health counseling based on Good Enough Sexual Model (GESM) versus PERMA (Positive Emotion, Engagement, Positive Relationships, Meaning, Accomplishment) on Sexual Function and Quality of Sexual Life in women
Comparing the effectiveness of sexual health counseling based on the good enough sexual experience model with the positivism approach on the performance and quality of women's sexual life
Design
A semi-experimental study is conducted using the method of a parallel clinical trial with two randomized parallel groups without blinding on the performance and quality of sexual life of 82 eligible women. Sampling is done by simple random allocation method using random allocation software. The intervention includes the GESM with the participation of 41 women and the PERMA with the participation of 41 women.
Settings and conduct
Bandar Abbas Comprehensive Health Center, invitation to study, sample selection, random allocation and psychological intervention are carried out by the second researcher, under the supervision of the first, third and fourth researchers.
Participants/Inclusion and exclusion criteria
Inclusion
Women of reproductive age (15-49 years)
Women living in Bandar Abbas city and having health records in comprehensive health centers
Being Iranian
Being married
Being the only spouse common platform
Have minimum literacy
Obtaining a score of less than 28 in the Rozen Women's Sexual Performance Index Questionnaire
Interested in participating in studying and doing homework;
Exclusion
Pregnancy
Breastfeeding
Sterility
Psychiatric diagnosis of depression and anxiety
No history of chronic diseases
Addiction to alcohol or drugs in oneself or one's spouse according to the woman's statement
Simultaneous participation in sexual education or counseling sessions
Intervention groups
For group A, four 90-minute sessions with an interval of one week in order to teach the (GESM), and for group B, 5 90-minute sessions based on the (PERMA) once a week in the house of the sampling center, will be held in person.
Main outcome variables
Change in the mean scores of sexual performance and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221219056866N1
Registration date:2023-01-15, 1401/10/25
Registration timing:registered_while_recruiting
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Sheila Ghasemzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3212 3274
Email address
sh.ghasemzadeh@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Sexual Health counseling based on Good Enough Sexual Model (GESM) versus PERMA (Positive Emotion, Engagement, Positive Relationships, Meaning, Accomplishment) on Sexual Function and Quality of Sexual Life in women
Public title
Comparison of Sexual Health counseling based on Good Enough Sexual Model (GESM) versus PERMA (Positive Emotion, Engagement, Positive Relationships, Meaning, Accomplishment) on Sexual Function and Quality of Sexual Life in women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age (15-49 years)
Women living in Bandar Abbas city and having health records in comprehensive health centers
Being Iranian
Being married
Being the only spouse
Having a common platform
Having at least reading and writing literacy
Obtaining a score of less than 28 in the Rozen Women's Sexual Performance Index Questionnaire
Interested in participating in studying and doing homework
Exclusion criteria:
Pregnancy
Breastfeeding
Sterility
Psychiatric diagnosis of depression and anxiety
Lack of medical history for chronic diseases
Addiction to alcohol or drugs in oneself or one's spouse according to the woman's statement
Simultaneous participation in educational sessions or sexual counseling
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research will be done by simple random allocation method. so that the second author (student) gave each woman a number from 1 to 82 based on the entry and exit criteria, and using random allocation software, the women were divided into two groups based on the randomization method (A: sexual experience model) Good enough and B: Perma model or positivism approach) are divided. At the beginning of the study, people are told that they have the same chance to be in each intervention group. So that except for the biostatistics researcher, no one (not the students, supervisors and advisors, nor the participants) knows in which group they will be allocatedEach group is divided into three sub-blocks. So that 41 participants in each intervention group are invited to 3 sub-groups (two groups of 14 people and one group of 13 people) for face-to-face counseling.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square; Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.SSU.REC.1401.067
Health conditions studied
1
Description of health condition studied
Sexual dysfunction counseling
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation
2
Description of health condition studied
Counseling the quality of sexual life
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation
Primary outcomes
1
Description
Changes in mean scores of sexual performance in women
Timepoint
In the baseline, completion of the intervention (week 4 in the good enough sexual experience model and week 5 in the positivism approach) and in the follow-up period (4 weeks after the completion of the intervention) in each group
Method of measurement
FSFI-female sexual function index (Rosen et al.)
Secondary outcomes
1
Description
Change in the mean scores of women's sexual life quality
Timepoint
In the baseline, completion of the intervention (week 4 in the good enough sexual experience model and week 5 in the positivism approach) and in the follow-up period (4 weeks after the completion of the intervention) in each group
Method of measurement
SQOL-F Sexual Life Quality Questionnaire (Simonds et al.)
Intervention groups
1
Description
Intervention group:The intervention in the group of good enough sexual experience model is done face-to-face and in a group at Bandar Abbas Comprehensive Health Center for 4 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes explaining the importance of sex as a vital element of life, the importance of the quality of sex and sexual satisfaction in the sexual development of couples, setting realistic expectations for sex, emphasizing physical health and healthy habits to restore sexual healthBehavioral education and counseling, paying attention to getting sexual pleasure as much as achieving proper sexual performance, counseling to overcome sexual fears and worries, training to have unusual sexual experiences, put aside idealistic ideas about sex, setting goals in Sex, getting to know the styles of sexual arousal, getting to know gender differences and accepting similarities and differences, strengthening communication skills, training the sexual desire cycle and counseling for personalizing sexual desire. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.
Category
Behavior
2
Description
Intervention group:The intervention in the positivism approach group is conducted face-to-face and as a group in the hall of Bandar Abbas Comprehensive Health Center for 5 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes positive emotions, engagement, positive relationship, meaning and achievement. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Comprehensive Health Center
Full name of responsible person
Mahshid Bokaie
Street address
Shahid Chamran Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
1388579166
Phone
+98 76 3333 3280
Email
mah_bokaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Alireza Moradi
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd,Dr. Bahnar Square,Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
alirezampr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bou Ali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After results publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Scientific usage.
From where data/document is obtainable
mah_bokaie@yahoo.com
What processes are involved for a request to access data/document