- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06716268
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students
November 29, 2024 updated by: Nesma Aziz Abd Elgany, Cairo University
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students: An Observational Study
The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Some pelvic floor physical therapists are beginning to experiment with using phonation and vocalization cues to elicit different pelvic floor movements .
However, there is a significant gap in the literature about the coordination and movement between the pelvic floor and glottis during speech and phonation, and there is an urgent need to identify the voices accompanied by increasing pelvic floor tone and integrating them into pelvic floor strengthening programs and voices accompanied by lowering pelvic floor tone and integrating them into pelvic floor down-training programs.
To date, there has been only one study describing pelvic floor displacement during vocalization tasks.
So this study aims to investigate pelvic floor muscle displacement during respiratory and phonatory tasks using trans-abdominal ultrasound to assess respiratory and phonatory tasks that can relax or enhance pelvic floor tone and be integrated into clinical practice.
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nesma A Elhofy, Bs.C
- Phone Number: 01015915487
- Email: nesma.aziz@cu.edu.eg
Study Contact Backup
- Name: Amira N Abdellattif, PhD
Study Locations
-
-
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Giza, Egypt
- Faculty of Physical Therapy Cairo University
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Contact:
- Nesma A Elhofy, Bsc
- Phone Number: 01015915487
- Email: nesma.aziz@cu.edu.eg
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Contact:
- Amira N Nagy, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Twenty healthy female university students will participate in this study.
They will be selected from faculty of physical therapy, Cairo University.
Description
Inclusion Criteria:
- 1. They should be virgin, healthy female physiotherapy students. 2. They have regular menstruation (3-8 days in duration, with 21-35 days in-between).
3. Their ages will range from 18 to 25 years old. 4. Their body mass index (BMI) will range from 18 to 24.9 Kg/m2. 5. Their waist- hip ratio will be less than (0.8).
Exclusion Criteria:
- Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
- Pelvic floor dysfunction.
Professionally trained singers.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Twenty healthy female university students
They will be selected from the faculty of physical therapy ,Cairo university
|
Participants performed various tasks to evaluate pelvic floor muscle activity and displacement.
These included a maximum voluntary contraction ("cutting off the flow of urine mid-stream"), a pelvic floor strain ("bearing down for a bowel movement"), and the Valsalva maneuver to clear the Eustachian tubes.
Additionally, phonation and respiratory exercises were conducted, such as producing the "ah" sound at different pitches, open-mouth exhalation, coughing, and semi-occluded vocal tract (SOVT) exercises using a small coffee straw, commonly used in singing warm-ups to enhance vocal efficiency.
Each task lasted 3 seconds, with 1-minute rest intervals to assess their impact on pelvic floor displacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of pelvic floor muscle displacement
Time Frame: 1 month
|
Pelvic floor displacement during phonation will be assessed using trans-abdominal ultrasound with a 3.5-MHz transducer.
Posterior bladder wall displacement will be measured in the sagittal plane with standardized markers at rest and maximal distortion.
A bladder filling protocol will ensure imaging clarity.
Participants will perform pelvic floor tasks (e.g., contraction, strain, Valsalva) and phonation/respiratory exercises (e.g., "ah" sounds, coughing, SOVT exercises).
Tasks will last 3 seconds, be repeated thrice, and baseline and end measurements will be recorded.
|
1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voice pitch classification
Time Frame: 1 month
|
the females' voice pitch will be classified by having them read "The North Wind and the Sun" three times consecutively in a quiet room, using a Samsung Note 20 mobile phone application for recording.
The microphone is placed 30 centimeters from their mouths.
The application measures average, median, highest (95th percentile), and lowest (95th percentile) frequencies in Hz to provide a comprehensive analysis of voice pitch and volume, aiding in assessing voice quality and potential disorders.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Doaa A Osman, PhD, Ass. prof.
- Study Chair: Amel M Yousef, PhD, PROFESSOR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 3, 2024
Primary Completion (Estimated)
January 3, 2025
Study Completion (Estimated)
January 10, 2025
Study Registration Dates
First Submitted
November 29, 2024
First Submitted That Met QC Criteria
November 29, 2024
First Posted (Estimated)
December 4, 2024
Study Record Updates
Last Update Posted (Estimated)
December 4, 2024
Last Update Submitted That Met QC Criteria
November 29, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005285
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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