Determining the effect of cognitive-behavioral therapy on sexual self-concept in postmenopausal women
Design
A clinical trial with a control group, randomized with a quadruple block on 66 postmenopausal women
Settings and conduct
The statistical population of this study in this study will include postmenopausal women referring to Amanieh health. Samples will be selected taking into account the entry and exit criteria. Samples will be randomly assigned with a block design in two groups of intervention (n = 33) and control (n = 33). No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Admission requirements: middle school and higher education, age range 45 to 55 years, normal menopause (not secondary to medication or surgery), marriage and living with a spouse, being at least 1 year apart and up to 5 years after termination Normal menstruation / conditions of non-entry: exposure to severe stress during the last 6 months, use of anti psychotic drugs, chronic illness, any psychological illness, previous history of using counseling techniques during the last 6 months, use of hormonal supplements During menopause
Intervention groups
The intervention group will receive 8 sessions of cognitive-behavioral counseling for 90 minutes. The control group will not receive any intervention.
Main outcome variables
Sexual self-concept
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201105049272N1
Registration date:2021-02-01, 1399/11/13
Registration timing:prospective
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Mahboobeh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2414
Email address
www.hosseinii.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Behavioral Therapy On Sexual Self-Concept in Postmenopausal Women
Public title
The Effect of Cognitive Behavioral Therapy On Sexual Self-Concept in Postmenopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Middle education and higher
Age range 45 to 55 years
Normal menopause (not secondary to medication or surgery)
Married and living with a spouse
Being at least 1 year and at most 5 years away from normal menstruation
Exclusion criteria:
Exposure to severe stress during the last 6 months
Taking anti psychotic drugs
Chronic disease
Having any mental illness
Previous history of using counseling techniques in the last 6 months
Use of hormonal supplements during menopause
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
By assigning samples to each of the intervention and control groups, it will be done by random block method and using quadruple blocks (by the table related to random permutations). Closed envelopes that are numbered will also be used to hide random allocation. In this way, each participant will be assigned a code and will be divided into two groups of control and intervention.
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.AJUMS.REC.1398.899
Health conditions studied
1
Description of health condition studied
Sexual self-concept
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual self-concept based on MSSCQ questionnaire
Timepoint
Before the intervention and after the intervention
Method of measurement
MSSCQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive 8 sessions of cognitive-behavioral counseling as a group for 90 minutes. The sessions will be held by a researcher who has received the necessary training and certification in cognitive-behavioral counseling, and the counseling professor will attend some sessions to ensure the correctness of the intervention, and finally a post-test will be taken after the sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 9
Full name of responsible person
مهرداد شریفی
Street address
Amaniyeh, corner of Bahman Street
City
Ahvaz
Province
Khouzestan
Postal code
0000000000
Phone
+98 61 3333 9194
Email
vchhealth@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Golestan Blvd., Esfand St., Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahboobeh Hosseini
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Amaniyeh, East Bouali St., Niayesh Building
City
Ahvaz
Province
Khouzestan
Postal code
6133933657
Phone
+98 61 3311 4325
Email
www.hosseinii.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
the coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd., School of Nursing and Midwifery, Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
tadayon-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahboobeh Hosseini
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Amaniyeh, East Bouali St., Niayesh Building
City
Ahvaz
Province
Khouzestan
Postal code
6133933657
Phone
+98 61 3311 4325
Email
www.hosseinii.m@ajums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After identifying the participants, information related to the main outcome will be shared.
When the data will become available and for how long
The publication of information will be possible 6 months after the publication of the results.
To whom data/document is available
Access to research documents is possible for research centers and researchers and therapists.
Under which criteria data/document could be used
Data are available with reference to the researcher's name and clinical and research procedures.
From where data/document is obtainable
Ahvaz University of Medical Sciences, School of Nursing and Midwifery, Ms. Mitra Tadayon Najafabadi
Mobile: 09166182793 Email: tadayon-m@ajums.ac.ir
What processes are involved for a request to access data/document
After correspondence with the Vice Chancellor for Research of Ahvaz University of Medical Sciences, the results are available.