Protocol summary
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Study aim
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Comparison of effectiveness sex counseling based on the GES and PLISSIT models on the sexual problems of menopausal women
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Design
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A controlled clinical trial with a control group, with parallel groups, double blind, randomized, on 108 postmenopausal women, block randomization method was used for randomization.
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Settings and conduct
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The list of all women aged 45 to 60 in the selected Urmia health center has been prepared and each of them will be contacted by phone, and if they are satisfied in visiting the relevant health care centers, the women will complete the FSFI questionnaire. If the FSFI score is 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 they were randomly assigned to groups A, B, and C.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group A will be treated based on the GES model. Intervention group B will be treated based on the PLISSIT model individually. The control group does not receive any counseling intervention and finally, after the end of the intervention, in order to comply with ethical considerations, the contents of the counseling will be provided to the group.
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Main outcome variables
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Sexual satisfaction, Quality of sexual life
General information
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Reason for update
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At the beginning of the study, two centers were selected as medical centers, and to speed up the study process, two medical centers were added to the list of diagnostic centers. A total of four centers were considered as study centers.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200122046228N4
Registration date:
2023-04-26, 1402/02/06
Registration timing:
registered_while_recruiting
Last update:
2023-10-24, 1402/08/02
Update count:
1
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Registration date
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2023-04-26, 1402/02/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-04, 1402/01/15
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Expected recruitment end date
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2023-09-22, 1402/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparison of the effect of sex counseling based on the GES model and the PLISSIT model on the sexual problems of menopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Randomization will be done using a block of six.
Ethics committees
1
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Ethics committee
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Approval date
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2023-03-12, 1401/12/21
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1401.255
Health conditions studied
1
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Description of health condition studied
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Sexual function disorder
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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Female sexual function
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Timepoint
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Before the start of the intervention and two months after the end of the intervention
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Method of measurement
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The 19-question scale of the Female Sexual Performance Index (FSFI) is used to evaluate sexual performance.
2
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Description
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Sexual satisfaction
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Timepoint
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Before the start of the intervention and two months after the end of the intervention
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Method of measurement
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Larson's 25-question sexual satisfaction scale will be used to evaluate sexual satisfaction.
Secondary outcomes
1
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Description
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Quality of sexual life
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Timepoint
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Before the start of the intervention and two months after the end of the intervention
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Method of measurement
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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
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Description
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Sexual intimacy
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Timepoint
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Before the start of the intervention and two months after the end of the intervention
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Method of measurement
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To evaluate sexual intimacy, the 30-question sexual intimacy scale will be used.
Intervention groups
1
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Description
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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 8-10 people). The first session of implementing the first three dimensions of the GES model and explaining the importance of sexual activity, teaching the definition of satisfaction and sexual performance and the factors affecting it, explaining the 4 stages of the sexual response cycle with an emphasis on the importance of knowing the sexual "desire" cycle, explaining the effect of menopause on sexual performance and its mechanism, encouraging the participants to write down their needs and expectations from sex, correcting misconceptions and superstitions about sex and creating an optimistic attitude. GES model, teaching healthy eating and performing Kegel exercises, teaching meditation skills and concentration exercises and three-minute breathing exercises, providing a time table to note down one's thoughts and mentality during pleasant and desirable sexual experiences, unpleasant experiences, dislike, Pain and contraction in body muscles, learning to enjoy each other. The third session of implementing the 7th, 8th and 9th dimensions of the GES model, taking into consideration the problems and concerns noted by the clients during the previous weeks, counseling for the appearance of adaptation to anatomical changes, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance Flirting and making love of couples, explaining and examining the pattern of sexual changes and possible physical problems after menopause and focusing on the five goals in Kamesh, identifying the five principles for sexual relations, accepting multiple goals from the parties, avoiding one-sided and inflexible goals. and clarifying the sexual program, describing different positions of intimacy and sexual stimulation styles, combining styles and creating diversity in the relationship. The fourth session of the implementation of the 10th, 11th and 12th dimensions of the GES model, counseling and training about the physical and psychological differences between men and women in each of the stages of the sexual cycle, communication skills training, creation skills training and maintaining intimacy.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available