The effectiveness of Eclectic Cognitive Behavioral and Psycho-educational Counselling on the sexual dysfunction of women referred to Imam Ali hospital in the city of Zarand in 2019
The effectiveness of Eclectic Cognitive Behavioral and Psycho-educational Counselling on the sexual dysfunction of women referred to Imam Ali hospital in the city of Zarand
Design
A clinical trial study has a control group.The statistical population includes 70 married women who come to the hospital clinic who have entry criteria and They will be randomly divided into two groups of intervention and control, which will be assigned to the coupled and individual days.
Settings and conduct
After a pretest, cognitive behavioral and psycho-educational group counselling sessions will be held in 8 sessions of 90 minutes, two sessions a weeks for the women in the intervention group and One month after the end of the sessions, the post-test is taken from both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Absence of any illness that affects sexual function
Do not take anti-hypertensive medications, antidepressants, antihistamines, birth control pills.
Married and living a stable life with her husband.
Not having substance abuse and alcohol in her spouse
Not being pregnant or breastfeeding
Having over 20 years of age and not being at the time of menopause
The absence of spouses of these women for early ejaculation or sexual discomfort, according to the person herself
The lack of mental illnesses such as depression
Previous undesirable sexual experience and aggression.
Lack of infertility
Earn a score lower than the cut point (score 28) in the questionnaire.
Desire to cooperate and complete the consent form.age of 20_50 years.
Exit :Exit yourself from studying and unwillingness to work together
Not attending counseling sessions in full
Intervention groups
Intervention in the form Eclectic Cognitive Behavioral and Psycho-educational Counselling for 8 sessions, each session 90 minutes, twice a week
Main outcome variables
Improvement of sexual dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N6
Registration date:2019-02-20, 1397/12/01
Registration timing:registered_while_recruiting
Last update:2019-02-20, 1397/12/01
Update count:0
Registration date
2019-02-20, 1397/12/01
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-15, 1397/11/26
Expected recruitment end date
2019-09-15, 1398/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Eclectic Cognitive Behavioral and Psycho-educational Counselling on the sexual dysfunction of women referred to Imam Ali hospital in the city of Zarand in 2019
Public title
Effectiveness of Eclectic Counselling on women sexual dysfunction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of any illness that affects sexual function (such as systemic diseases, including liver, kidney and heart failure, diabetes, thyroid failure, malignant diseases).
Do not take anti-hypertensive medications, antidepressants, antihistamines, birth control pills
Married and living a stable life with her husband
Not having substance abuse and alcohol in her spouse
Not being pregnant or breastfeeding
The absence of spouses of these women for early ejaculation or sexual discomfort, according to the person herself
The lack of mental illnesses such as depression
Previous undesirable sexual experience and aggression
Lack of infertility
Earn a score lower than the cut point (score 28) in the questionnaire
Desire to cooperate and complete the consent form
age of 20 _50 years
Exclusion criteria:
Exit yourself from studying and unwillingness to work together
Not attending counseling sessions in full
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Kerman University of Medical Sciences
Street address
Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-02-13, 1397/11/24
Ethics committee reference number
IR.KMU.REC.1397.429
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual dysfunction
Timepoint
Before intervention and one month after intervention
Method of measurement
Femal Sexual Function Index questionnaire
Secondary outcomes
1
Description
Sexual dysfunction
Timepoint
Before intervention and one month after intervention
Method of measurement
Femal Sexual Function Index questionnaire
Intervention groups
1
Description
Intervention group: Intervention in the form of cognitive behavioral and psycho-educational group counselling in women with a sexual function score of 28 or less are twice weekly for 90 minutes over a period of 4 weeks in the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital of Zarand
Full name of responsible person
Zahra Zangiabadizadeh
Street address
Zarand Imam Ali Hospital
City
Zarand
Province
Kerman
Postal code
7613694333
Phone
+98 34 3342 5000
Email
zahra.zangiabadizadeh@gmil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhty
Street address
Haft-Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5220
Email
drpardakhti@yahoo.com
Web page address
http://www.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr Atefeh Ahmadi
Position
proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman Haft-Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Firoozeh Mirzaee
Position
proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kerman Haft-Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
F_mirzaee@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Atefeh Ahmadi
Position
proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman Haft-Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main research consequences after the completion of research work is available.
When the data will become available and for how long
Start accessing the data immediately after printing the results.
To whom data/document is available
Researchers in academia are able to access research data.
Under which criteria data/document could be used
Use of data is permitted for use in supplementary research.
From where data/document is obtainable
The applicant can contact the researcher to receive information via email.
monashirzad1992@yahoo.com.
zahra.zangiabadizadeh@gmail.com
What processes are involved for a request to access data/document
After submitting a written request from the applicant, the data will be provided to him as soon as possible.