Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Primary Purpose
Pelvic Floor Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
pelvic floor contraction
Sponsored by
About this trial
This is an interventional screening trial for Pelvic Floor Muscle Weakness focused on measuring pelvic diaphragm, Physiotherapy students, education
Eligibility Criteria
Inclusion Criteria:
- healthy students
- willing to participate in the study
Exclusion Criteria:
- has been treated before for pelvic floor rehabilitation
- active urinary tract infection
- pregnancy
- previous abdominal surgeries
Sites / Locations
- Haifa University, Department of PHysical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
after "women health" course
before "women health" course
Arm Description
The participants will be instructed to contract the pelvic floor muscle
The participants will be instructed to contract the pelvic floor muscle
Outcomes
Primary Outcome Measures
direction of urinary bladder displacement during contraction
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
urinary bladder displacement in millimeters
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Secondary Outcome Measures
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917615
Brief Title
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Official Title
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Detailed Description
Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.
The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness
Keywords
pelvic diaphragm, Physiotherapy students, education
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups according to the year of physiotherapy school.
Masking
Participant
Masking Description
Participants will not know the aim of study
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
after "women health" course
Arm Type
Experimental
Arm Description
The participants will be instructed to contract the pelvic floor muscle
Arm Title
before "women health" course
Arm Type
Active Comparator
Arm Description
The participants will be instructed to contract the pelvic floor muscle
Intervention Type
Other
Intervention Name(s)
pelvic floor contraction
Intervention Description
Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
Primary Outcome Measure Information:
Title
direction of urinary bladder displacement during contraction
Description
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
Time Frame
baseline
Title
urinary bladder displacement in millimeters
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
baseline
Secondary Outcome Measure Information:
Title
pelvic floor muscles endurance of contraction in seconds
Description
time of muscle contraction will be measured during the last contraction
Time Frame
baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy students
willing to participate in the study
Exclusion Criteria:
has been treated before for pelvic floor rehabilitation
active urinary tract infection
pregnancy
previous abdominal surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa
Official's Role
Study Director
Facility Information:
Facility Name
Haifa University, Department of PHysical Therapy
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results
IPD Sharing Time Frame
one year
Citations:
PubMed Identifier
30152550
Citation
Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.
Results Reference
result
Learn more about this trial
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
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