Determine the impact of sexual counseling on the quality of life of married elderly women
Design
A clinical trial was conducted in two groups: control and test, randomized, double blind, with a sample size of 30 people in each test and control group.
Settings and conduct
The location of the municipality's buildings is located in the 6th district of Tehran. After random sampling, two groups of control and test, each group consisting of 30, were determined by the consultant, and the researcher and the participants were not aware of the samples from the two groups, then 4 sessions of the classroom and 4 sessions of telephone counseling The test group is held and the control group does not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: elderly people who are married; age range 60 to 70 years old; having reading and writing skills; the absence of significant cognitive impairment (such as dementia, Alzheimer's and ...); able to communicate verbally and in an eye; the absence of important life events such as divorce, death of loved ones and ... in a recent month; absence of depression and anxiety disorders; do not take antidepressants and anti-anxiety drugs; failure to receive previous training in sexual matters.
Exit criteria: participants' reluctance to continue their research; not attending training sessions more than twice in a row; start cognitive problems during research; start acute visual and acuity hearing problems while conducting research; death.
Intervention groups
The samples are divided into two groups of test and control; for the test group, 4 sessions of the training class and 4 sessions of telephone counseling are conducted and the control group does not receive any intervention.
Main outcome variables
Sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180904040946N1
Registration date:2018-10-06, 1397/07/14
Registration timing:registered_while_recruiting
Last update:2018-10-06, 1397/07/14
Update count:1
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Fatemeh Shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 8228
Email address
f.shahabi87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the Effect of Sexual Counseling on Sexual Quality of Life in Married Elderly Women
Public title
Effect of Sexual Counseling on Sexual Quality of Life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people are married
Age range 60 to 70 years old
Having reading and writing skills
The absence of significant cognitive impairment (such as dementia, Alzheimer's and ...)
Able to communicate verbally and in an eye
The absence of important life events such as divorce, death of loved ones and ... in a recent month
Absence of depression and anxiety disorders
Do not take antidepressants and anti-anxiety drugs
Failure to receive previous training in sexual matters
Exclusion criteria:
Participants' reluctance to continue their research
Not attending training sessions more than twice in a row
Start cognitive problems during research
Start acute visual and acuity hearing problems while conducting research
Death
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and Researcher are not aware of the examples of the two test and control groups, and The Statistic Counselor randomly places the subjects in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Faculty of Nursing and Midwifery of Tehran and Rehabilitation
At the beginning of the study and 3 months after the beginning of Group and Telephone counseling
Method of measurement
Sexual Quality of Women Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:30 patients were selected randomly as intervention group and completed the demographic questionnaire and sexual quality of life. For the intervention group, four sessions of two-hour weekly one-time group training and four weekly telephone counseling sessions are held once. After one month, the sexual quality of life questionnaire is completed by the intervention group.
Category
Lifestyle
2
Description
Control group: Thirty people are in control group who will not receive any training or counseling.
Dr mirkhani (East Nursing), Tohid Square, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4124
Email
Spoortaghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fateme shahabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr Mirkhani (East Nursing), Tohid Square, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5585 8228
Email
F.shahabi87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sarieh poortaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr mirkhani (East Nusrat), Tohid Square, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 61054
Email
Spoortaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme shahabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr Mirkhani (East Nursing), Tohid Square, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5585 8228
Email
F.shahabi87@yahoo.com
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
Article, In the end, the results of the study will be publicly available
When the data will become available and for how long
A year after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
After correspondence with the research team
From where data/document is obtainable
Fateme shahabi
What processes are involved for a request to access data/document
The request has been addressed to Ms. Fatemeh Shahabi then Mrs. Shahabi shared the request with the research team and After the research team agrees, the documentation will be provided by email to the applicant.