Comparison of two exercise methods (kegel and Swiss ball) on sexual distress and sexual function in women undergoing hemodialysis
Design
In this study, 45 patients with dialysis entry conditions who referred to dialysis department of Kamkar, Shahid Beheshti and Vali Asr hospitals were randomly divided into two groups of intervention and one control group and each participant A code is assigned
Settings and conduct
This study will be conducted in the physiotherapy department of 3 hospitals. Eligible patients undergoing dialysis will be randomly assigned to a hospital under the intervention of Kegel Sports, at another Swiss ball, and no interventions will take place at the third hospital. pelvic contraction will measure with biofeedback device Before and after intervention. Also, the female sexual dysfunction index will be completed before and after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female sex, age 18 and under 50 years of age, sexual dysfunction based on the female sexual dysfunction index, at least 6 months after the onset of hemodialysis
exclusion criteria:Unwillingness to cooperation, smoking
Intervention groups
1. The first intervention group perform Kegel exercises for 3 times a day for 5 weeks.
2. The second intervention group performs Swiss-wing exercises for 15 sessions and 3 sessions per week under the supervision of a physiotherapist.
3. Control group: will not be subjected to an intervention.
Main outcome variables
The most important outcome of this study is the improvement of female sexual dysfunction in female under hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171107037294N2
Registration date:2018-05-23, 1397/03/02
Registration timing:retrospective
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
mahsa haji mohammad hoseini
Name of organization / entity
qom university of mrdical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3771 1060
Email address
mhajhoseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom university of medical sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two exercise methods (kegel and Swiss ball) on sexual distress and sexual function in women undergoing hemodialysis
Public title
Comparison of two methods of exercise on women's sexual function under hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Age over 18 and under 50 years of age
Literacy of reading and writing
Sexual dysfunction based on Gender Women's Sexual Function Index
No hospitalization in the last 6 months
Passed at least 6 months from the start Hemodialysis
married
Exclusion criteria:
Unwillingness to continue cooperation
Fatal or sickening
Smoking
Known Types of Neuropathy and Neoplasia or Genitourinary Abnormalities
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental assignment is a simple randomization of hospitals to intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, one intervention will be performed in each of the three hospitals and all participants will not be aware of how other interventions are carried out.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences.
Street address
Saheli st., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Approval date
2017-10-31, 1396/08/09
Ethics committee reference number
IR.MUQ.REC.1396.98
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
ICD-10 code description
2
Description of health condition studied
patient under hemodialysis
ICD-10 code
I12.0
ICD-10 code description
Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease
Primary outcomes
1
Description
sexual function
Timepoint
before and after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: they will perform Kegel exercises. For 3 times a day (morning, evening and night, and 15 to 20 times each time), for 5 weeks, the pelvic floor muscles are shaken for 10 seconds. Then put 10 seconds to rest, will do. After receiving the necessary training by the nurse and the physiotherapist and confirming the physiotherapist's correctness, the group trained daily at the hospital three times a week (before or after dialysis) and exercises in the presence of a physiotherapist. It will take 20 minutes
Category
Rehabilitation
2
Description
Intervention group2: they perform Swiss-ball exercises for 15 sessions and 3 sessions per week (before or after dialysis) and 20 minutes per session in a relaxed and appropriate environment under the supervision of a physiotherapist.
Category
Rehabilitation
3
Description
Control group:they will be selected as a control group and will not be interfered with.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
ُShahid Beheshti Hospital
Full name of responsible person
Maryam Marvi
Street address
Shahid Beheshti Blvd., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 25 3612 2000
Email
Marvi_pt@yahoo.com
2
Recruitment center
Name of recruitment center
Kamkar-Arabniya Hospital
Full name of responsible person
Maryam Marvi
Street address
19Dey St., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 25 3771 3511
Email
Marvi_pt@yahoo.com
3
Recruitment center
Name of recruitment center
VAlieasr hospital
Full name of responsible person
Maryam Marvi
Street address
Jomhouri Blvd., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 25 3288 4310
Email
Marvi_pt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
No. 83, 1/1 Alley, Safashahr St., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 25 3285 2720
Email
dr.hosseinsaghafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
Mahsa Haji Mohammad Hosseini
Position
instructor, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences, saheli st., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 25 3771 1060
Fax
Email
mhajhoseini@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
mahsa Haji Mohammad Hosseini
Position
Instructor, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences, saheli st., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 257711060
Fax
Email
mhajhoseini@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahsa Haji Mohammad Hosseini
Position
instructor, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences, Saheli St., Qom
City
Qom
Province
Ghoum
Postal code
3715736994
Phone
+98 253209073
Email
mhajhoseini@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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