ClinicalTrials.gg
Not yet recruitingNCT06716268Updated Dec 4, 2024

Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students

An observational study in Pelvic Floor Dyssynergia and Phonation Disorder, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 24 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Pelvic Floor Dyssynergia
  • Phonation Disorder

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03

In context

Dysphonia

132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.

This study's planned enrollment of 20 is below the median of 123 across 40 observational studies indexed under Dysphonia.

Browse Dysphonia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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).
  1. Their ages will range from 18 to 25 years old. 4. Their (BMI) will range from 18 to 24.9 Kg/m2. 5. Their waist- hip ratio will be less than (0.8).

Exclusion criteria

Exclusion Criteria:

  1. Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
  2. Pelvic floor dysfunction.
  3. Professionally trained singers.

    -

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Twenty healthy female university students

    They will be selected from the faculty of physical therapy ,Cairo university

    Other: phonation and respiratory tasks

Interventions

  • Otherphonation and respiratory tasks

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 month

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Jan 2025, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2024
First posted
Dec 4, 2024
StartEst.
Dec 3, 2024
Primary completionEst.
Jan 3, 2025
CompletionEst.
Jan 10, 2025
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06716268
Lead sponsor
Cairo University
Responsible party
Nesma Aziz Abd Elgany (principal investigator, Cairo University) — Principal investigator
First posted
Dec 4, 2024
Start date
Dec 3, 2024 (estimated)
Primary completion
Jan 3, 2025 (estimated)
Completion
Jan 10, 2025 (estimated)
Last update
Dec 4, 2024

Study contacts

Nesma A Elhofy, Bs.C
Contact
nesma.aziz@cu.edu.eg
01015915487
Amira N Abdellattif, PhD
Contact
Doaa A Osman, PhD
study director · Ass. prof.
Amel M Yousef, PhD
study chair · professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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