Protocol summary
-
Study aim
-
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:
2019-05-28, 1398/03/07
Update count:
1
-
Registration date
-
2018-10-06, 1397/07/14
-
Registrant information
-
-
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
-
No information
-
Sample size
-
Target sample size:
30
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Sample randomization
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-09-04, 1397/06/13
-
Ethics committee reference number
-
IR.TUMS.FNM.REC.1397.107
Health conditions studied
1
-
Description of health condition studied
-
Quality of Life
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Sexual Quality of Life
-
Timepoint
-
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
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.
-
Category
-
N/A
1
-
Sponsor
-
-
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
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.
-
Comments
-