Determining The Impact of Group Sexual counseling Based on Theory of Self-Determination on The Type of Sexual Motivation and Sexual Function of Women
Design
A randomized controlled clinical trial was conducted randomly (centers were selected as lotteries), from September 2018 to January 2019.
Settings and conduct
Health Centers -The researcher is referred to health centers that have been selected randomly and after the sampling is available, they conduct group counseling for the intervention group and non-Internationale group in the control group.
Participants/Inclusion and exclusion criteria
His wife and wife tend to participate in the research.
Have read and write literacy.
Iranian and other cities
Living together.
The woman is the only partner of her husband's life.
Age over 18 and under 49 years of age.
A woman or her husband has no special medical conditions (diabetes - blood pressure - epilepsy)
A woman or her husband has no mental illness
Pregnant and lactating, and not intending to have a pregnancy during the study
Intervention groups
Two groups of control and intervention
The intervention group has sexual counseling.
The control group receives the usual care.
Main outcome variables
Sexual Motivation - Sexual Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180726040602N1
Registration date:2019-07-09, 1398/04/18
Registration timing:retrospective
Last update:2019-07-09, 1398/04/18
Update count:0
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Maryam سالاری هدکی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 5467
Email address
salarim3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-02-03, 1397/11/14
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2019-02-03, 1397/11/14
Trial completion date
2019-02-03, 1397/11/14
Scientific title
"The Impact of Group Sexual Counseling Based on Theory of Self-Determination on the type of sexual Motivation and Sexual Function of women
Public title
"The Impact of Group Sexual Counseling Based on Theory of Self-Determination on the type of sexual Motivation and Sexual Function of women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
She and her husband have a desire to participate in this research.
Have literacy to read and write.
Be Iranian and live in Mashhad
She is living with her husband.
She is the only partner of her husband's life.
Age over 18 and under 49 years of age.
A woman or her husband has no special medical conditions (diabetes - blood pressure - epilepsy)
A woman or her husband has no mental illness
Pregnant and lactating, and not intending to have a pregnancy during the study.
Exclusion criteria:
postmenopausal
use effective medications for sexual performance
There is alcohol or substance abuse
The conditions that prevent their sexual intercourse
a stressful incident in the last six months that can affect their sexual performance.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street,Mashhad,Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.017
Health conditions studied
1
Description of health condition studied
Types of sexual and sexual function and the effect of counseling type consistent with self-determination theory on the type of sexual stimulation and sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Type of motivation and sexual function
Timepoint
At the beginning of the study
Method of measurement
The score obtained from the questionnaire
Secondary outcomes
1
Description
Change the type of sexual Motivation
Timepoint
One month after the intervention
Method of measurement
The score obtained from the questionnaire
2
Description
Upgrading sexual function
Timepoint
One month after the intervention
Method of measurement
The score obtained from the questionnaire
Intervention groups
1
Description
Control group: Receive routine care and do not interfere. The group completes the "Theory Structural Questionnaire, the type of sexual motivation, and Sexual Functioning of FSFI Women" at the beginning and one month later.
Category
Behavior
2
Description
Intervention group: In the beginning of the study, the group completed the questionnaire of theoretical constructs, the type of sexual motivation and sexual function scale of FSFI women, and then 5 sessions of 2-hour group sexual counseling based on self-determination theory with a one week interval and after One month after the last meeting, they complete the questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Mashhad
Full name of responsible person
Mahin Tafazzoli
Street address
Mashhad Nursing Midwifery Faculty, Ebn Sina Ave,Mashhad,Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177911111
Phone
+98 51 3869 6754
Email
salarim3@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, University Street,Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177513650
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,University Avenue, St,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
کد پستی : 9137913199
Phone
+98 5138591511051
Fax
+98 51 3859 7313
Email
salarim3@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences,University Avenue,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 338591511009851
Fax
+98 51 3859 7313
Email
tafazolim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Salari Hadaki
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, University Avenue,Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 338591511009851
Fax
+98 51 3859 7313
Email
salarim3@mums.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
No - There is not 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
Collectively, changes in the type of sexual stimulation and sexual function of women before and after intervention are published
When the data will become available and for how long
Since 1399
6 months after printing results
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
Unknown
From where data/document is obtainable
Mashhad University of Medical Sciences
What processes are involved for a request to access data/document