NCT07111650

Brief Summary

The trunk is divided into the thoracic cavity above and the abdominal cavity below by the thoracic diaphragm. The vocal cords are located in the upper region of the thoracic cavity, in the area between the folds known as the larynx. The pelvic floor is a multilayered muscular sling that is located in the lower part of the abdomen. There is a relationship between the pelvic floor and the larynx through fascial connections along the trunk . Pelvic floor muscles (PFM) play an important role in bowel and bladder continence, sexual function, lift abdominal and pelvic organs, regulation of intra-abdominal pressure and maintenance of respiration and posture. The larynx has many important functions such as protecting the airway, facilitating natural breathing, producing phonation or sound, increasing intra-abdominal pressure during straining, defecation, micturition and labour. Structural integrity and functionality between the respiratory, laryngeal or phonation levels and the resonant cavities are essential for correct voice production. The pelvic floor, thoracic diaphragm and larynx move simultaneously caudally when inhaling and cranially when exhaling, like a piston. Voice is produced by the larynx during expiration when air passes through the trachea, setting the vocal cords into vibration. The tension of the vocal cords and sufficient subglottal pressure are essential for phonation. Additionally, the abdominal muscles play a crucial role in controlling the expiratory phase of speech by counteracting the recoil pressures of the lungs. This allows for the production of longer utterances and the maintenance of subglottal pressure throughout phonation.Voice hygiene and proper breathing techniques are crucial for both professional and non-professional voice users such as singers, academics, call center employees, and religious leaders. Healthy sound production requires PFM stability, balanced abdominal muscles, and effective respiratory control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

April 25, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

acoustic analysisElectromyographyPelvic floor musclephonationVoice

Outcome Measures

Primary Outcomes (2)

  • Pelvic floor muscle activity

    Pelvic floor muscle strength and endurance were assessed using the Neurotrac® Myoplus 2 Pro two-channel EMG Biofeedback device. One channel's electrodes were placed in the anal region to assess the pelvic floor muscles, while the other channel's electrodes were placed on the transversus abdominis, with a reference electrode located on the thigh. Initially, the participant was instructed on how to contract and relax the pelvic floor muscles, followed by a trial period.

    Baseline

  • Acoustic Voice Analysis

    Both the recordings and the analyses were performed in the same laboratory using the Kay Elemetrics Computerised Speech Lab (CSL) KayPENTAX Model 4500 system. Recordings were made using a KayPENTAX CSL Model 4500 unit and a Shure SM48 microphone connected to a desktop computer. Participants were seated on a chair in front of the computer, and the microphone was positioned at a 45-degree angle, 10 cm away from the speaker's mouth. All recordings were saved in the CSL programme as sound files (nsp) with a sampling rate of 44.01 kHz and a resolution of 24-bits. Data analyses were performed on the same computer and device. Participants were instructed to produce a natural and relaxed /a/ phonation without straining or raising their voice, similar to how they normally speak in daily life.

    Baseline

Secondary Outcomes (2)

  • Maximum phonation time

    Baseline

  • s/z ratio

    Baseline

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Being volunteer
  • Age between 18- 40 years

You may not qualify if:

  • urological, gynecological, respiratory, or vocal disorders,
  • cognitive or perceptual problems,
  • being pregnant,
  • being in the premenstrual or menstrual phase on the evaluation day,
  • having allergies, cold, or flu on the evaluation day,
  • perineal sensitivity,
  • any surgery in the abdominal, stomach, respiratory, laryngeal, and/or head and neck regions,
  • vocal complaints for at least 15 days,
  • hearing complaints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kutahya Health Sciences University

Kütahya, Merkez, 43020, Turkey (Türkiye)

Location

Kutahya Helath Sciences University- Health Sciences Faculty

Kütahya, Merkez, 43020, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

August 8, 2025

Study Start

May 1, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

August 8, 2025

Record last verified: 2025-04

Locations