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The effect of sexual counseling based on the BETTER model on sexual function and sexual dysfunctional beliefs in postmenopausal women referred to comprehensive health services affiliated to Shahid Beheshti University of Medical Sciences

Protocol summary

Study aim
Determining the effect of sexual counseling based on the BETTER model on sexual functioning and dysfunctional sexual beliefs in postmenopausal women
Design
The present study is a clinical trial with pre-test and post-test design with control group. The groups are parallel and the allocation of samples in two groups of 53 will be done randomly.
Settings and conduct
This study will be performed on 106 menopausal women under the comprehensive health service centers affiliated to Shahid Beheshti University of Medical Sciences. Two centers will be randomly selected and will be randomly assigned to the control and intervention groups. The intervention group will receive two individual counseling sessions of 60 to 90 minutes with an interval of 1 week. The control group will receive usual menopausal care and a pamphlet prepared by the research team.
Participants/Inclusion and exclusion criteria
Inclusion criteria: iranian, literacy, at least one year has passed since menopause, in the first ten years of menopause, having sexual activity, not using hormone therapy and chemical and herbal drugs affecting sexual function, without surgical histories such as hysterectomy, oophorectomy, cystocele, and rectocele. Exclusion criteria: unwillingness to continue participating in the research, cessation of sexual activity.
Intervention groups
The intervention group will have two individual counseling sessions of 60 to 90 minutes, one week apart. In the first session, the first three stages of the model, including bring up, explain, and tell, will be implemented. In the second session, the next three stages, including time, education, and record, will be implemented. The control group, will not receive counseling based on the BETTER model and the usual care will be provided along with the pamphlet prepared by the research team.
Main outcome variables
Sexual function; Dysfunctional sexual beliefs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150128020854N12
Registration date: 2023-10-12, 1402/07/20
Registration timing: registered_while_recruiting

Last update: 2023-10-12, 1402/07/20
Update count: 0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling based on the BETTER model on sexual function and sexual dysfunctional beliefs in postmenopausal women referred to comprehensive health services affiliated to Shahid Beheshti University of Medical Sciences
Public title
The effect of sexual counseling based on the BETTER model on sexual function and sexual dysfunctional beliefs in postmenopausal women referred to comprehensive health services affiliated to Shahid Beheshti University of Medical Sciences
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- At least one year has passed since the last menstruation. 2- Being in the first ten years of menopause. 3- Have sexual activity. 4- Do not use hormone replacement therapy. 5- Have not undergone hysterectomy, oophorectomy, cystocele, rectocele, and mastectomy. 6- Their spouses do not suffer from sexual problems. 7- Do not use chemical or herbal drugs effective on sexual function. 8- Premature menopause has not happened. 9- Do not suffer from depression, anxiety, and stress (according to the results of the DASS questionnaire).
Exclusion criteria:
1_ Unwillingness to continue participating in the study. 2_ Interruption of sexual activity during the study for any reason (such as illness, death of spouse).
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
First, two centers will be randomly selected from the comprehensive health service centers affiliated to Shahid Beheshti University of Medical Sciences. Then randomly one center will be assigned to the intervention group, and one center will be assigned to the control group by lottery. Then, from the medical record numbers of the women who meet the inclusion criteria, 53 people will be selected in each center by lottery. Based on the lottery in the control center, those whose last digit of their file number is odd and in the intervention center those whose last digit of their file number is even will enter the study after the lottery.
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 Beheshti University of Medical Sciences, School of Nursing and Midwifery
Street address
Vali-e-Asr St - Niayesh Intersection- In front of Shshid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.070

Health conditions studied

1

Description of health condition studied
Sexual counselling
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention, 4 week after intervention
Method of measurement
Female sexual function index

2

Description
Dysfunctional sexual beliefs
Timepoint
Before the intervention, 4 week after intervention
Method of measurement
A self-designed questionnaire for dysfunctional sexual beliefs

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the women of the intervention group will have two individual counseling sessions of 60 to 90 minutes, one week apart. The content of the sessions is based on the sexual problems raised by women, which will be implemented according to the BETTER model. The first session: The purpose of this session is to create a sense of security and peace in the client and to normalize sexual discourse and reduce the client's sense of shame. The counselor simply talks about sexual issues with the client and tells them that he can talk quite easily. In fact, normalization of the problem is done in this step (first step, Bring up). Then the consultant talks to the client about the importance and impact of sexual issues, especially after menopause, on the quality of life, and gives brief explanations about the function of the sexual organs after menopause and common problems during this period, and about the fact that not treating sexual problems is possible. has effects on married life, gives explanations and it will be said that the client is completely free to talk about this. Then, by asking a few open questions about the client's sexual problem and concern, he will be asked if he has ever discussed this with his wife, thus encouraging the client to talk (second step, explain). Then solutions are given according to their main problem and the counselor assures the client that he will provide all the necessary information to solve his problem (third stage, tell). At the end of the session, the client is asked to discuss his sexual concerns with his wife and list his sexual problems again. At the same time, apply the provided solutions. The second session: The purpose of this session is to increase the client's sense of confidence in the availability of the counselor and to increase the ability to manage sexual problems by herself, as well as to correct misconceptions related to sexual issues after menopause. First, it is requested to express the result of the action regarding the solutions presented in the previous session, especially the conversation with her husband, and express her sexual problems again, and then according to the prioritization of the problems, the duration of the consultation is based on the preference and readiness of the client. It is determined and since the restoration of sexual relationship is an ongoing process, the counselor will be available to address the concerns and answer the client's questions. For this purpose, the researcher will answer their questions by providing them with a contact number at specific hours (fourth step, time). In this meeting, which is held according to the client's preparation and request, the consultant first asks the client's opinion about the previous meeting and the effect of the proposed solutions to be recorded in his file. The counselor is informed by the client's knowledge about how to deal with sexual problems after menopause, so he is asked which of the strategies he used to solve the problem was effective and in order to correct the misconceptions about intimacy after menopause. Menopause is attempted (stage 5, education). Then the counselor provides more complete training about the client's sexual problem. (Continuation of the training of the first session). In the sixth stage of the BETTER model,(stage 6, Record), evaluations, interventions and treatment outcomes of the client are recorded. Women's sexual function questionnaires (FSFI) and sexual dysfunctional beliefs were made by the researcher before the intervention and 4 weeks after the end of the intervention by the company. will be completed.
Category
Other

2

Description
Control group: for the control group, no intervention with the BETTER model will be carried out during the research, and only the usual interventions and the presentation of pamphlets prepared by the research team will be carried out, but after the end of the research, they will be invited to receive advice based on the above model.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pardis comprehensive health service center
Full name of responsible person
Elnaz Ariafar
Street address
Edalat square, South Farvardin St, Behind Imam Ali Mosque
City
Pardis
Province
Tehran
Postal code
1658133841
Phone
+98 21 7629 7300
Email
pardis@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Boumehen comperehensive health servises center
Full name of responsible person
Elham Najafi
Street address
Boumehen, behind the fire station, mehrab St
City
Boumehen
Province
Tehran
Postal code
1656195583
Phone
+98 21 7623 5040
Email
pardis@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Street address
Vali-e-Asr St- Niayesh Intersection- In front of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
s.hajian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Bahri
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St- Niayesh Intersection- In front of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
negin.bahri1376@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hedyeh Riazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali-e-Asr St - Niayesh Intersection- In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.riazi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Bahri
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St- Niayesh Intersection- In frort of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
negin.bahri1376@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
If there is a logical reason, it will be provided to the journal for publication of the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristics and findings related to the main outcome variable will be published in the paper.
When the data will become available and for how long
After the publication of the paper
To whom data/document is available
Researchers
Under which criteria data/document could be used
other statistical analysis
From where data/document is obtainable
Dr. Hedyeh Riazi h.riazi@sbmu.ac.ir
What processes are involved for a request to access data/document
After counseling with the research team, the data will be provided to the applicant, which will be probably a one-month process
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