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Investigate the effect of sex life enrichment training program on attitude, function, and sexual quality of life in postmenopausal women based on a solution-focused approach

Protocol summary

Study aim
The aim of this study is to determine the effect of sexual life enrichment training program on the attitude, function and quality of sexual life of postmenopausal women.
Design
A clinical trial with a control group, randomized, intervention, and control groups of 72 people each and random allocation will be performed in a cluster.
Settings and conduct
From the health service centers affiliated to Qazvin University of Medical Sciences, 4 pairs of health centers will be selected. Random allocation will be done in a cluster so that in selected centers close to each other with similar socio-economic conditions, the centers are selected in pairs and the clients of each pair of centers are randomly assigned to one of the two intervention or control groups. Questionnaires to assess attitude, performance and, quality of sexual life are completed as a pre-test. Post-test is held immediately and one month after the intervention. The collected data are then analyzed before and after the intervention and the results are interpreted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian women, married, sexually active, have at least a literacy education and are in the first ten years of menopause, are not on hormone therapy, have not experienced a stressful event in the last six months, their wives and husbands, do not have a severe physical or mental illness. Non Inclusion criteria: unwillingness to continue participating in the study, undergoing any type of surgery, losing a spouse and incurable disease.
Intervention groups
Two groups will participate in this research. The intervention group will be provided with a sex life enrichment training program and the control group will be provided with routine care.
Main outcome variables
The main outcomes of the study include attitude, function and quality of sexual life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150128020854N11
Registration date: 2022-06-02, 1401/03/12
Registration timing: prospective

Last update: 2022-06-02, 1401/03/12
Update count: 0
Registration date
2022-06-02, 1401/03/12
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
Investigate the effect of sex life enrichment training program on attitude, function, and sexual quality of life in postmenopausal women based on a solution-focused approach
Public title
Investigate the effect of sex life enrichment training program on attitude, function, and sexual quality of life in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian Have at least a literacy education Be married Be sexually active Be in the first ten years of menopause Do not face a stressful event in the last six months (such as an accident, serious illness, or loss of loved ones) Women and their husbands do not have a known mental illness (according to the woman) Women and their husbands do not have severe physical illnesses (such as uncontrolled diabetes, limited mobility) (according to the woman) They are not on hormone therapy Have no history of hysterectomy or mastectomy Women and their husbands should not use drugs that are effective in sexual activity (such as Sildenafil) (according to the woman) Women and their husbands should not smoke, drink alcohol, or use drugs (according to the woman) Have not had a serious marital conflict (such as a divorce / the thought of divorce) in the last six months (according to the woman) No sexual dysfunction in the spouse such as erectile dysfunction and ejaculation (according to the woman)
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is that first Qazvin city is divided into 4 regions according to socio-economic conditions. Then, two comprehensive health centers with the highest number of clients will be assigned to each region. To prevent the possibility of exchanging information between individuals in the intervention and control groups, the selected centers in each region are randomly assigned to the intervention or control group using a table of random numbers. Therefore, in each area, we will have two centers, one for the intervention group and one for the control group. Then, postmenopausal women under the auspices of the above centers who are eligible to enter the study will be invited to participate in the study and after providing a full explanation and obtaining informed consent will enter the study. Therefore, sampling in each center will be available based on inclusion criteria and this sampling will continue until the number of samples in each center reaches 18 people.
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
Street address
St Velenjak, Shahid Chamran Highway, Shahid Beheshti University Of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.306

Health conditions studied

1

Description of health condition studied
Sexual life of postmenopausal women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual Attitude Score in Sexual Attitude Assessment Questionnaire
Timepoint
Measurement of sexual attitude at the beginning of the study (before the intervention), immediately and 1 month after the intervention
Method of measurement
Sexual Attitude Assessment Questionnaire

Secondary outcomes

1

Description
Sexual function score in the Sexual Function Questionnaire
Timepoint
Measurement of sexual function at the beginning of the study (before the intervention), immediately and 1 month after the intervention
Method of measurement
Sexual Function Questionnaire

2

Description
Sexual quality of life score in Sexual quality of life Questionnaire
Timepoint
Measurement of sexual quality of life at the beginning of the study (before the intervention), immediately and 1 month after the intervention
Method of measurement
Sexual Quality of Life Questionnaire

Intervention groups

1

Description
We will divide 72 people in the intervention group into four groups, each group will be 18 people, and sex life enrichment training sessions with a solution-oriented approach will be held in groups in comprehensive health service centers. In 4 sessions of 90-60 minutes, the training program will be held by the researcher (Ph.D. student in reproductive and sexual health) who has passed the course related to problem-solving and has succeeded in obtaining the certificate of completion of the course. The goals of the above training sessions are as follows, the first session: introduce people, and start to set goals (goals in a positive, clear, and achievable way in marital and sexual dimensions). Session 2: Helping group members to realize positive abilities and capabilities in previous encounters with marital and sexual life challenges. Session 3: Helping to discover the exceptions to life in the marital identity and sexual life of members (disrupting thought, behavioral and emotional patterns that disrupt life). Session 4: Helping to adopt different mental, behavioral and emotional ways of facing challenges. In all sex life enrichment training sessions, the researcher will answer the participants' questions. Attitudes, practices, and quality of sex life will be measured and compared before and after the intervention (immediately and one month after the sessions).
Category
Lifestyle

2

Description
Control group: 72 people in the control group will not receive any intervention. Before, immediately and one month after the training sessions, attitude, performance and quality of sexual life will be evaluated and compared. After the end of this research, life enrichment will be implemented for the educational groups in order to observe the ethical principles.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bolandian Comprehensive Health Service Center
Full name of responsible person
Alireza Mehr Alian
Street address
Qazvin, Shahid Babaei Ave, Shahid Bolandian Comprehensive Health Service Center
City
Qazvin
Province
Qazvin
Postal code
3414763111
Phone
+98 28 3365 5035
Fax
+98 28 3365 8060
Email
infobhc@qums.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
School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@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
Elnaz Haji Rafiei
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
No. 33, Keramat Alley, Modares Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413816341
Phone
+98 28 3333 4574
Email
Elnazhajirafiei@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
School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
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
Elnaz Haji Rafiei
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Science, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
Email
Elnazhajirafiei@gmail.com
Web page address

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 variables 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 consulting with the research team, the data will be provided to the applicant, which will probably be a one-month process.
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