NCT06716268

Brief Summary

The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 29, 2024

Last Update Submit

November 29, 2024

Conditions

Outcome Measures

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.

    1 month

Secondary Outcomes (1)

  • Voice pitch classification

    1 month

Study Arms (1)

Twenty healthy female university students

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

Other: phonation and respiratory tasks

Interventions

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

Twenty healthy female university students

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \- 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).
  • \. 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Dysphonia

Interventions

Phonation

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Doaa A Osman, PhD

    Ass. prof.

    STUDY DIRECTOR
  • Amel M Yousef, PhD

    professor

    STUDY CHAIR

Central Study Contacts

Nesma A Elhofy, Bs.C

CONTACT

Amira N Abdellattif, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 4, 2024

Study Start

December 3, 2024

Primary Completion

January 3, 2025

Study Completion

January 10, 2025

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations