Comparison the effect of walking and kegel exercise on sexual dysfunction of lactating women
Design
A randomized, controlled clinical trial with a parallel group design of 180 lactating women, will enroll and follow for 3 months.
Settings and conduct
Health Centers of Kermanshah
Participants/Inclusion and exclusion criteria
Inclusion criteria: lactating women without unknown psychiatric problems or systemic illness; without stressful events in the last 6 months; Married and live with a permanent partner; Being in the 40 days to 6 months of postpartum period; have exclusive breastfeeding; total score ≤ 28 from the Rosen Sexual function Questionnaire; have ability to contract pelvic floor muscles and Singleton delivery. Exclusion criteria: Drug dependence, Marital discord, Unwillingness to participate in the study
Intervention groups
Intervention 1: Walking exercise
Intervention 2: Kegel Exercise
control group
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170305032900N4
Registration date:2019-11-09, 1398/08/18
Registration timing:registered_while_recruiting
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Sousan Heydarpour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 2679
Email address
sheydarpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of performing walking and kegel exercise on sexual dysfunction of lactating women
Public title
The effect of exercise on sexual dysfunction of lactating women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
lactating women without unknown psychiatric problems or systemic illness which have an effect on sexual function; Stressful events have not occurred to them in the last 6 months; Married and live with a permanent partner; use a safe contraceptive method, during lactation (40 days to 6 months postpartum); have exclusive breastfeeding; total score ≤ 28 from the Rosen Sexual function Questionnaire; have ability to contract pelvic floor muscles and Singleton delivery.
Exclusion criteria:
Drug dependence , Marital discord, Unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
At first samples are selected by convenience sampling method then they will be randomly divided into three groups (two intervention and one control group). Then 180 cards that look exactly alike are numbered from one to 180 and pour into a box. Participants will be asked to bring out a card.The first 60 people are assigned to walking group, the next 60 people and the final 60 people are assigned to kegle and control group respectively.
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
Ethics committee of kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard; Central Building of Kermanshah University of Medical Sciences
City
kermanshsh
Province
Kermanshah
Postal code
6715847141
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.KUMS.REC.1397.784
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
score of sexual function in Rosen Female Sexual Function Index
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Completion of Rosen Women's Sexual Function Index
Secondary outcomes
1
Description
خالی
Timepoint
خالی
Method of measurement
خالی
Intervention groups
1
Description
Intervention group1: Group members will be instructed to walk 30 to 60 minutes three times a week and submit to the relevant checklist.
Category
Rehabilitation
2
Description
Intervention group 2: People will be trained to do kegel (Pelvic floor muscle contraction) exercises twice a day and submit to the relevant checklist.
Category
Rehabilitation
3
Description
Control group: They do not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Health Centers
Full name of responsible person
parisa shadab
Street address
School of Nursing and Midwifery, Isar Square, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
67156334766
Phone
+98 83 3826 6429
Email
fac_n.m@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology, Shahid Beheshti Boulevard, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی کرمانشاه
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
sheydarpour@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
sheydarpour@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Isar Square, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
sheydarpour@kums.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
No - There is not 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
All participants data can be shared after being unidentified
When the data will become available and for how long
Start the access period after publishing the results