Comparison of the effectiveness of sex counseling based on the GES (good enough sex) model and PLISSIT ( permission, limited information, specific suggestions, and intensive therapy) model on the sexual problems of menopausal women: A controlled trial study
Comparison of effectiveness sex counseling based on the GES model and the PLISSIT model on the sexual problems of menopausal women
Design
Randomized controlled clinical trial
Settings and conduct
The list of all women aged 45-60 in selected Urmia health center is prepared from the Sib system and each one of them will be contacted by phone and if they agree, In the face-to-face visit at the relevant health centers, women will complete the FSFI questionnaire. If they FSFI score less than 28, they will be included in the study after obtaining written informed consent. Then, they completed Larson's sexual satisfaction instruments, women's sexual quality of life (SQOL-F), sexual intimacy and then randomly assigned to groups A, B, and C.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: women in age range between 45 and 60 years; being married; complete cessation of menstruation in the last 12 months without the use of drugs or surgery; Literacy of reading and writing; Being monogamy; having a stable sexual relationship in the last 4 weeks; scoring less than 28 in the Female Sexual Function Index (FSFI);
Exclusion Criteria: addicted to drugs and alcohol; participating in any educational-counseling classes before or during the study; history of chronic physical and mental illness with self-report.
Intervention groups
Intervention group A will be treated based on the GES model. Intervention group B will be treated based on the PLISSIT model individually. The duration of treatment for both groups is similar, 4 sessions, once a week for 60 minutes. The control group does not receive any counseling intervention, and finally, after the end of the intervention and evaluations, to comply with ethical considerations, the contents of the counseling will be available to the group.
Main outcome variables
sexual satisfaction, quality of sexual life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046228N4
Registration date:2023-04-26, 1402/02/06
Registration timing:registered_while_recruiting
Last update:2023-04-26, 1402/02/06
Update count:1
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of sex counseling based on the GES (good enough sex) model and PLISSIT ( permission, limited information, specific suggestions, and intensive therapy) model on the sexual problems of menopausal women: A controlled trial study
Public title
Comparison of the effect of sex counseling based on the GES model and the PLISSIT model on the sexual problems of menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed written consent to participate in the study
complete cessation of menstruation in the last 12 months without the use of drugs or surgery
Literacy of reading and writing
Spouse's availability in the last 4 weeks and having sex
scoring less than 28 on the Female Sexual Function Index (FSFI)
Having documents in health-care centers in Uromiyeh city
Married women between 45 to 60 years old
Being monogamy
Exclusion criteria:
Having known physical and mental illnesses according to self-report and constant use of medicine under the supervision of a doctor
Taking drugs that affect sexual function (Sildenafil, antidepressants, antihistamines, diazepam, barbiturates, amphetamines, antihypertensive drugs, cocaine, etc.)
Addiction or habitual consumption of alcohol by women
Participating in other similar studies
Occurrence of an unpleasant event during the 3 months before the study (death or serious illness of close relatives
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
random assignment to one of the three study groups; (three groups A, B and C), the block randomization method with block size of 6 will be used. Then, according to the block randomization protocol (Randomization list using statistical program in R software environment version 3.6.1), the participants will be divided into one of the three groups: GES, PLISSIT, and the control group; They will be allocated with a ratio of 1:1:1, so that the researcher cannot predict which group the next person will be placed in the intervention group in each center. The participants are allocated to three groups of 36 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using a block of six.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Health Research Institute-Babol University of Medical Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Midwifery Department, Dr. Fatemeh Nasiri Amiri
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.255
Health conditions studied
1
Description of health condition studied
Sexual function disorder
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
female sexual function
Timepoint
before the start of the intervention and two months after the end of the intervention
Method of measurement
The 19-question scale of the Female Sexual Performance Index (FSFI) is used to evaluate sexual performance.
2
Description
Sexual satisfaction
Timepoint
before the start of the intervention and two months after the end of the intervention
Method of measurement
Larson's 25-question sexual satisfaction scale will be used to evaluate sexual satisfaction.
Secondary outcomes
1
Description
Quality of sexual life
Timepoint
before the start of the intervention and two months after the end of the intervention
Method of measurement
To evaluate the quality of sexual life, the 18-question questionnaire of the quality of sexual life of women (SQOL-F) will be used.
2
Description
sexual intimacy
Timepoint
before the start of the intervention and two months after the end of the intervention
Method of measurement
To evaluate sexual intimacy, the 30-question sexual intimacy scale will be used.
Intervention groups
1
Description
Intervention first group: in this group, women will receive sexual counseling in 4 sessions, 60 minutes, once a week, based on the concepts of the GES treatment model in a group (maximum 8 people). One session of these sexual counseling sessions is considered as individual counseling based on the client's problem and to answer their private questions. The content of the first and second sessions includes an overview of the anatomy and physiology of the male and female reproductive system, false sexual beliefs, the definition of sexual satisfaction and the factors affecting it, the dimensions of correct sexual communication and the definition of sexual self-knowledge, sexual self-disclosure, sexual differences between men and women, the cycle Sexual response, proper conditions for correct sexual intercourse and sexual deviations. The third and fourth session on designing sexual relations based on the conditions of each couple and their desires, methods of creating diversity in sexual relations, definition of sexual fantasy, definition of sexual desire, definition of disorder of decreased desire and sexual stimulation, factors affecting sexual desire, description Physical and psychological factors affecting sexual desire, the description of social-educational and interpersonal factors affecting sexual desire will be emphasized based on the dimensions of the therapeutic model.
Category
Treatment - Other
2
Description
The second intervention group: In this group, women will receive sexual counseling during 4 sessions, 60 minutes, once a week based on the PLISSIT sexual counseling-therapy model, which includes permission, limited information, specific suggestions, and focused treatment. First step: permission; It means that the client should talk freely about his concerns in the sexual field. Also, at this stage, many sexual behaviors without problems that the patient has previously experienced are allowed to speak. Second stage: limited information; The therapist gives limited information about the patient's concerns. Third stage: exclusive offers; The patient is given specific suggestions to enable him to manage his sexual problems. Fourth stage: focused treatment; Psycho-sexual treatment is performed by the researcher and psychiatrist of the team. In order to prevent samples from falling and respond to their treatment problems, the researcher will be in regular contact with women between visits. Interventions will be free for participants.
Category
Treatment - Other
3
Description
Control group: The control group does not receive any intervention, and they will be under routine care according to the integrated care of menopausal women, and finally, after the end of the intervention and evaluations, due to ethical considerations, the contents of the consultation will be provided to the control group in the form of a compact CD file.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive healthcare centers
Full name of responsible person
Samira barjaste
Street address
Kilometer 11 of Saro Road - Nazlo Campus - School of Nursing and Midwifery.
City
Urmia
Province
West Azarbaijan
Postal code
15335-57561
Phone
+98 914 715 5545
Fax
Email
Samira_barjaste_70@yahoo.com
2
Recruitment center
Name of recruitment center
Sahih Health Center
Full name of responsible person
Leila Ali Aghdami
Street address
Sahih Health Center, Delgosha Ave., Baath 3 St. (Ataei)
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3223 6060
Email
leila_aghdami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Ganj Afrooz St.,Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
Ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
University associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St.,
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz St., Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri- Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
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