Comparison of the effect of two intervention methods (pelvic floor exercise and moisturizing cream) on sexual function and disparity in women undergoing systemic cancer
Determining the effect of two interventions (pelvic floor exercise and moisturizing cream) on sexual function and dyspareunia in women with systemic cancer
Design
90 patients with systemic cancer have 30 patients in each of the three groups
This study is a double-blind study
Settings and conduct
Iran Mehr Health Center in Birjand
Participants/Inclusion and exclusion criteria
1. The informed consent of the patient and his wife to enter the study
2-Patients aged 20 to 50 years.
3. Cancer that is systemically treated.
4. Sexual dysfunction, which is specified in the FSFI questionnaire with a score below 25.
5. Do not take medication to help improve sexual dysfunction and vaginal dryness if you take these medications before interrupting your medication.
6. Non-incontinence of urine and stool and kidney and bladder cancer
7. Not having a catration history in the last two months
8. Not being treated for mental disorders (depression and anxiety).
9-Urethrocole, Rectosyl and Cystocel grid 3 and above
Intervention groups
Pelvic floor exercise group
control group
Moisturizing cream group
Main outcome variables
Sexual Function, Dispensary, Moisturizing Cream, Pelvic Floor Exercise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190619043952N1
Registration date:2019-08-20, 1398/05/29
Registration timing:retrospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
saeedeh irandoost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
saeedeh.irandoost@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-05, 1398/05/14
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two intervention methods (pelvic floor exercise and moisturizing cream) on sexual function and disparity in women undergoing systemic cancer
Public title
Comparison of the effect of two intervention methods (pelvic floor exercise and moisturizing cream) on sexual function and disparity in women undergoing systemic cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. The informed consent of the patient and his wife to enter the study2-Patients aged 20 to 50 years.3. Cancer that is systemically treated.4. Sexual dysfunction, which is specified in the FSFI questionnaire with a score below 25.5. Do not take medication to help improve sexual dysfunction and vaginal dryness if you take these medications before interrupting your medication.6. Non-incontinence of urine and stool and kidney and bladder cancer7. Not having a catration history in the last two months8. Not being treated for mental disorders (depression and anxiety).9-Urethrocole, Rectosyl and Cystocel grid 3 and above.10-Absence of vaginal infection and urinary tract infection11-Incidence of pelvic fracture12. Do not be breastfeeding
Exclusion criteria:
1-Patient dissatisfaction with the continuation of the intervention2. Cancer recurrence and lack of response to treatment3-pregnancy
Age
From 25 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
30
We will select 90 patients with systemic cancer and then randomly place 30 people in each of the three control groups, moisturizing cream and pelvic floor exercises.
Randomization (investigator's opinion)
Randomized
Randomization description
After referring to Birjand Iran Mehr Medical Center in Iran and completing the questionnaire regarding gender, vocabulary monitoring, selection and gender questionnaire. Anyone who is under 25 is eligible for the daily questionnaire and can be arranged. Martian dyspareunia may contact you within two months, we can use these specialists with financial services. Genital, urethral, rectocele, systocele (grade 3) have been rejected. The Oxford Fingerprint Limit can be completed by you. If you want to be asked to serve as a Guidance Manager in three 30-person groups. Considering the type of cancer and age,Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in other groups are unaware
A gynecologist who performs gynecological examinations is unaware of the type of intervention performed for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.BUMS.REC.1397.159
Street address
Birjand University of Medical Sciences, Birjand, Iran
City
bhrjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.BUMS.REC.1397.159
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual dysfunction
Timepoint
Sexual function measurement one month after the intervention, two months after the intervention and two months after the end of the intervention
Method of measurement
Sexual Function Questionnaire of Rosen Women, Marinop's Scale, Linear Pain Scale, Oxford Scale
Secondary outcomes
1
Description
Pelvic floor exercise, moisturizing cream
Timepoint
Sexual function measurement one month after the intervention, two months after the intervention, and finally two months after the end of the intervention.
Method of measurement
Rosen Sex Function Questionnaire, Linear Pain Tool, Marinop Scale, Oxford Scale
2
Description
Dyspuronia
Timepoint
Sexual function measurement one month after the intervention, two months after the intervention, and finally two months after the end of the intervention.
Method of measurement
Rosen Sex Function Questionnaire, Linear Pain Tool, Marinop Scale, Oxford Scale
Intervention groups
1
Description
Intervention group: Intervention group: First, Marin.F and Oxford Sexual Performance Inventory and a linear pain relief tool for one month. The moisturizing cream and the second one are performed for one month of pelvic floor exercise. Then the questionnaire is completed. In the second month of the intervention, it is repeated for the load The second questionnaire will be completed and two months will be considered a faloo-up and completed for the fourth time of the questionnaires.And compared to the control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran health center in Birjand
Full name of responsible person
Ahmad reza sebzari
Street address
South Khorasan Province, Birjand
City
birjand
Province
South Khorasan
Postal code
7197178444
Phone
+98 56 3162 6800
Fax
+98 56 3162 6899
Email
iranmehr@bums.com
Web page address
https://iranmehr.bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Street address
South Khorasan, Birjand, Ghafari St., Central Organization of Birjand University of Medical Sciences
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Position
Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Birjand, South Khorasan Province
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 1406
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Position
Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Birjand, South Khorasan Province
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Position
Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
خراسان جنوبی، بیرجند، خیابان غفاری، سازمان مرکزی دانشگاه علوم پزشکی بیرجند
City
birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1406
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Questionnaires, statistical information
When the data will become available and for how long
After finishing the research work
To whom data/document is available
University of Medical Sciences
Under which criteria data/document could be used
At the request of the relevant organization
From where data/document is obtainable
Ahmad Nasiri
What processes are involved for a request to access data/document
At the written request of the research vice president