Determine the Effect of sexual health discharge planning on the sexual function of patients undergoing (TURP)
Design
The research community is TURP patients in the Urology Department of Bahman Zanjan Hospital.
After initial evaluation, the patients are entered into intervention and control groups based on the random allocation of the 4th block.
The sample size was calculated based on the literature review.
The discharge planning for intervention group is based on a valid and standard program.
Settings and conduct
this study is a randomized control trial with intervention and controll group.
The research area is the Urology Department Bahman Zanjan Hospital.
Intervention is also a training program for discharge from the time of entry to the time of discharge in 3 sessions 30 to 45 minutes.
Participants/Inclusion and exclusion criteria
Age under 85 years.
Do not use of antidepressants, anti-psychotic drugs, phosphodiesterase inhibitors and addictive drugs.
Having satisfaction of client.
Not having untreated psychological problems.
Having no history of pelvic floor muscle surgery and CABG.
Not having atherosclerotic diseases and nervous system.
Intervention groups
discharge planning is being developed in the role of Psychological state and convictions in sexual function, the role of fatigue in sexual function, exercise pelvic floor muscles to improve performance and sexual activity with control of urinary incontinence and other mechanisms, the role of physical activity in improving sexual function and the importance of the management of lower urinary tract symptoms and urinary incontinence satisfaction of sexual function and desire to do it.
For the control group, training was also carried out on the standard of department.
Main outcome variables
sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180917041052N1
Registration date:2018-10-29, 1397/08/07
Registration timing:registered_while_recruiting
Last update:2018-10-29, 1397/08/07
Update count:0
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
Ramin Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3355 3313
Email address
baiatramin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-25, 1398/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual health discharge planning on the sexual function of patients undergoing transurethral resection of prostate (TURP)
Public title
The effect of sexual health discharge planning on the sexual function of patients undergoing transurethral resection of prostate (TURP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men under the age of 85 under TURP surgery.
not Consumption of antidepressants or anti-psychotic drugs.
Lack of addictive substances such as opium, alcohol and cocaine compounds.
Not participating in previous sexual health programs.
Having patient satisfaction to participate in the study.
Married men.
Not having untreated psychological problems.
Have not history of pelvic floor muscle surgery.
No use of phosphodiesterase inhibitors (PDE).
Having no history of CABG.
Lack of atherosclerotic diseases, skeletal and muscular disorders that prevent excessive mobility of the patient.
Lack of diseases affecting the nervous system, such as multiple sclerosis, hypogonadism, hyperprolactinemia, dementia, Parkinson's disease, and spinal cord injury.
Exclusion criteria:
Not being educated of client
Age
To 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
the samples will randomly assign to the control and intervention groups by quadruple block method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Nursing and Rehabilitation faculty of Tehran
Street address
Faculty of Nursing and Midwifery. East Nusrat Street. Tohid Street. Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2300
Health conditions studied
1
Description of health condition studied
Benign Prostate Hyperplasia and TURP Surgery
ICD-10 code
N40
ICD-10 code description
Benign prostatic hyperplasia
Primary outcomes
1
Description
sexuall function
Timepoint
Before the intervention. One and three months after the intervention
Method of measurement
based on the IIEF-15 questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:in the design of discharge planning, focus was placed on an educational program based on sexual health. its content was based on evidence (from literature review). The program focuses on the role of mental status and beliefs in sexual functioning, the role of fatigue on sexual function, the role of pelvic floor muscle exercises in improving function and sexual activity by controlling urinary incontinence and other mechanisms, the role of physical activity and exercise in sexual performance recovery , And the importance of managing the symptoms of the lower urinary system and urinary incontinence on sexual satisfaction and willingness to do.This program will accomplish in three sessions from 30 to 45 minutes from admission until to discharge. At the end, the booklet will give to the patient or companion patient, and the researcher's telephone number will give to the client for answer the patient questions.
Category
Treatment - Other
2
Description
Control group: For the control group, training will be performed Based on the standard of the Urology Department
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Urology, Bahman Hospital of Zanjan
Full name of responsible person
Ramin Bayat
Street address
22 Bahman Highway. Bahman Hospital
City
Zanjan
Province
Zanjan
Postal code
45196-44491
Phone
+98 24 3355 3313
Email
baiatramin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Ramin Bayat
Street address
22 Bahman Highway. Bahman Hospital
City
Zanjan
Province
Zanjan
Postal code
4519644491
Phone
+98 24 3355 3313
Email
baiatramin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
50
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
Faculty of Nursing and Midwifery
Full name of responsible person
Ramin Bayat
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plaque 39. Shahid Hami Ebrahim Khani Alley. 17 Shahrivar Street
City
Zanjan
Province
Zanjan
Postal code
45196-44491
Phone
+98 24 3355 3313
Email
baiatramin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Bayat
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plaque 39. Shahid Hami Ebrahim Khani Alley. 17 Shahrivar Street
City
Zanjan
Province
Zanjan
Postal code
4519644491
Phone
+98 24 3355 3313
Email
baiatramin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Bayat
Position
MSc Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Plaque 39. Shahid Hami Ebrahim Khani Alley. 17 Shahrivar Street
City
Zanjan
Province
Zanjan
Postal code
4519644491
Phone
+98 24 3355 3313
Fax
Email
baiatramin@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The abstract, the title of the statement, the method of submission and discussion, and the conclusions will be published.
Content available for statistical analysis will be published.
In the case of samples, the process is not coded or run.
In case of customer satisfaction, proprietary information will be quoted with encoding.
When the data will become available and for how long
After completing the study, its contents will be published in prestigious journals
To whom data/document is available
All people
Under which criteria data/document could be used
In order to improve the sexual function of patients under turp
From where data/document is obtainable
Related magazine site
What processes are involved for a request to access data/document
Available data can be submitted to applicants after request