Pelvic Floor DyssynergiaNCT06716268
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students
An observational study of Pelvic Floor Dyssynergia and Phonation Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dyssynergia, Phonation Disorder
- What is being tested?
- phonation and respiratory tasks
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2024to 10 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Twenty healthy female university students will participate in this study. They will be selected from faculty of physical therapy, Cairo University.
Who may be able to join
- 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).
Who cannot join
- Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
- Pelvic floor dysfunction.
- Professionally trained singers.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amira N Abdellattif, PhD contact
Egypt1 site
Faculty of physical therapy Cairo university
Giza
Nesma A Elhofy, Bsc, 01015915487, nesma.aziz@cu.edu.eg
Amira N Nagy, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Dyssynergia, Phonation Disorder
- Being tested
- phonation and respiratory tasks
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonation and respiratory tasksOther
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
| Study group | Role | What they receive |
|---|---|---|
| Twenty healthy female university students | They will be selected from the faculty of physical therapy ,Cairo university Receives: Other: phonation and respiratory tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pelvic floor muscle displacement
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.
Measured: 1 month
Secondary outcomes (1)
Voice pitch classification
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start3 Dec 2024 (estimated)
- Primary completion3 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DyssynergiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Aziz Abd Elgany, Cairo University
- Investigators
- Doaa A Osman, PhD, Study director, Ass. prof.Amel M Yousef, PhD, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716268
- Sponsor's protocol ID
- P.T.REC/012/005285
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students: An Observational Study
- ClinicalTrials.gov ID
- NCT06716268
- Acronym / sponsor ID
- P.T.REC/012/005285
- Conditions
- Pelvic Floor Dyssynergia, Phonation Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (estimated)
- Primary completion
- 3 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twenty healthy female university students | – | Other: phonation and respiratory tasksThey will be selected from the faculty of physical therapy ,Cairo university |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty healthy female university students will participate in this study. They will be selected from faculty of physical therapy, Cairo University.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
- Pelvic floor dysfunction.
- Professionally trained singers.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phonation and respiratory tasksParticipants 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 | Other | Twenty healthy female university students |
Primary outcome
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 secondary outcome
Voice pitch classification
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amira N Abdellattif, PhD contact
Doaa A Osman, PhD study director
Ass. prof.
Amel M Yousef, PhD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dyssynergia and Phonation Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nesma A Elhofy, Bs.C (01015915487, nesma.aziz@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic floor muscle displacement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.