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The Effect of Sexual Counseling with Cognitive-Behavioral Therapy approach on Sexual Function of Menopausal women

Protocol summary

Study aim
The effect of cognitive-behavioral counseling on sexual function of postmenopausal women
Design
Random assignment to intervention and control groups
Settings and conduct
The first stage is selected by random cluster from the triple zones of the city of Kashan. Six centers (from each region of the two centers) are selected by lot. In the next stage, between the two centers, a center will be selected as the intervention group and the center will be the control group based on the draw. Was .
Participants/Inclusion and exclusion criteria
Marital status, lack of addiction in couples, lack of couples with diabetes, lack of sensory and motor skills in couples, having reading and writing skills, normal menopause, age 45-60 years old, in the first 5 years after menopause Being, amenorrhea for more than a year, monogamy, lack of menopause at the age of less than 40 years, lack of stressful experiences in the last three months, natural sexuality of the spouse According to the person himself and not taking herbal remedies containing phytoestrogens or sexual supplements Exit criteria: Missing more than two sessions at CBT sessions. Wife's death or separation from her during study.
Intervention groups
Of eligible eligible menopausal women who are willing to participate in the research, they will be continuously sampled, followed by a completed questionnaire, and screening will be performed, and those who have a score of HNS performance less than 28 will be included in the research project. . Sampling will last as long as the prescribed sample size reaches the quintile. Consultative councils will be formed in the presence of clinical psychologists in groups of 10 persons twice a week in 8 sessions for the intervention group.
Main outcome variables
The effect of cognitive-behavioral counseling on desire, psychological stimulation, humidity, orgasm, satisfaction and sexual pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160709028847N5
Registration date: 2019-02-09, 1397/11/20
Registration timing: registered_while_recruiting

Last update: 2019-02-09, 1397/11/20
Update count: 0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
leila Neisani
Name of organization / entity
Iran University Medical of Science
Country
Iran (Islamic Republic of)
Phone
+98 88006990
Email address
neisanisamani.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Sexual Counseling with Cognitive-Behavioral Therapy approach on Sexual Function of Menopausal women
Public title
The Effect of Sexual Counseling with Cognitive-Behavioral Therapy approach on Sexual Function of Menopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality Marital status Being Muslim Not being in the profession of psychology and psychiatry No addiction in couples Not having couples to have diabetes Not having sensory and motor disturbances in couples Have reading and writing skills Do not use sedative medications Menopause The age of a woman is 45 to 60 years old In the first 5 years after menopause Amenorrhea for more than a year Monogamy Missing menopause at age 40 Not having acute heart disease and any acute mental illness in couples Lack of stressful experiences in the last three months The normal nature of the spouse's sexual power, according to one's own words Not taking herbal remedies containing phytoestrogens or sexual enhancers in any form.غيبت بيش از دو جلسه در جلسات CBT.
Exclusion criteria:
Missing more than two sessions at CBT sessions The occurrence of stressful events during the study Wife's death or separation from her during study
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research is multi-stage. The first step is selected in a cluster of three areas of the city of Kashan, six centers (from each district of two centers) by lot, and in the next stage, between the two centers, based on the drawing of one The center will be the control group as the intervention group and the other center. In the next step, the researcher will attend the centers from the first to the weekend from 8 am to 12 noon, and will be sampling in the appropriate manner among eligible postmenopausal women who are willing to participate in the research. The questionnaire will then be completed by the clients and screening for sexual function will be performed and those who score less than 28 will enter the research plan. Sampling will continue as long as the prescribed sample size reaches the quid pro quo.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.IUMS.REC.1397.532

Health conditions studied

1

Description of health condition studied
The Impact of Sexual Counseling on the Cognitive-Behavioral Approach of Postmenopausal Women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive behavioral counseling
Timepoint
Immediately after intervention, 1 month and two months after intervention
Method of measurement
Sexual Function of Women's Sexual Function Index (FSFI)

Secondary outcomes

1

Description
Sexual function
Timepoint
Immediately after intervention, 1 month and two months after intervention
Method of measurement
Questionnaire 19 questions (FSFI)

Intervention groups

1

Description
Intervention group: The sample size is 60. The members of the two intervention and control groups complete the pre-test in the first session. Then, the intervention team participates in interventional sessions based on a cognitive-behavioral approach that includes 8 sessions. The control group does not receive intervention. At the end of the sessions, both groups respond to the post-test. Also, in the follow up phase immediately after the intervention, one month and two months later, the two groups will again respond to the questionnaire questions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Akramian Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Martyr Morteza Akramian Alley, Opposite Bu-Ali Specialized Polyclinic, 22 Bahman Ave
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5545 3656
Email
name@domian.com

2

Recruitment center
Name of recruitment center
Shahid Manavi Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Hekmat 55- Bolivar Boulevard is Rovanandi
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5557 9228
Email
health@kaums.ac.ir

3

Recruitment center
Name of recruitment center
Golabchi Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Imam Khomeini street
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5546 5850
Email
name@domian.com

4

Recruitment center
Name of recruitment center
Shahid Bahonar Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Shahid Dimi Alley, Beheshti Street
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5546 5959
Email
health@kaums.ac.ir

5

Recruitment center
Name of recruitment center
Sadeghpour Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Imam Javad Crossroads, Isfahan Door Street
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5522 1133
Email
health@kaums.ac.ir

6

Recruitment center
Name of recruitment center
Samimi Health Center
Full name of responsible person
Leila Neissani Samani
Street address
Ascension 39, Natanz Street
City
Kashan
Province
Isfehan
Postal code
-
Phone
+98 31 5523 7394
Email
health@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Neissani Samani
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
1
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
Iran University of Medical Sciences
Full name of responsible person
Leila Neissani Samani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
neisanisamani.l@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
leila Neisani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
neisanisamani.l@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
leila Neisani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 88006990
Fax
Email
neisanisamani.l@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Sexual function and its components will be calculated in both groups at the time of entering the research and after the intervention. Using descriptive statistics methods, the two-dimensional frequency distribution tables are set and the quantitative indices of the quantitative variables are also divided into two Calculate the group and then homogeneity tests, homogeneity of the two groups of evaluators. Then, using the t test, we will compare the variables of the two groups. Meanwhile, the pairwise exits will be used to compare before and after quantitative variables. Covariance analysis will be used to control covetails and will be used in the SPSS16 software version.
When the data will become available and for how long
18 months
To whom data/document is available
Dr. Zahra Zanjani - Dr Hamid Haqani
Under which criteria data/document could be used
To analyze
From where data/document is obtainable
Dr. Zahra Zanjani - Dr Hamid Haghani - Dr. Leila Neissani
What processes are involved for a request to access data/document
1/5 years
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