HealthyNCT07111650
Relation of Pelvic Floor Muscle and Phonation
An observational study of Healthy, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Being volunteer
- Age between 18- 40 years
Who cannot join
- 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,
Show all 9Show fewer
- any surgery in the abdominal, stomach, respiratory, laryngeal, and/or head and neck regions,
- vocal complaints for at least 15 days,
- hearing complaints.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kutahya Health Sciences University
Kütahya, Merkez, 43020
Kutahya Helath Sciences University- Health Sciences Faculty
Kütahya, Merkez, 43020
About this study
Official title: Relationship Between Pelvic Floor Muscle Activity and Voice Acoustic Parameters in Young Adults
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
- Conditions
- Healthy
- Keywords
- acoustic analysis, Electromyography, Pelvic floor muscle, phonation, Voice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
Maximum phonation time
Voice recordings for maximum phonation time (MPT) were recorded using the CSL device, and analyses were performed on the same system. For the MPT, participants were instructed to take a deep breath and produce a long /a/ phonation at a normal pitch and loudness until they ran out of breath, without holding or pausing their breath. This measurement was repeated three times, and the average duration across the three trials was calculated in seconds.
Measured: Baseline
s/z ratio
Voice recordings for the s/z ratio were recorded using the CSL device, and analyses were performed. For the s/z ratio, participants were asked to take a deep breath and produce a long /s/ phonation at a normal pitch and loudness until they ran out of breath. The entire procedure was repeated three times. They were instructed to perform the same process three times with the /z/ phonation. After calculating the maximum duration of both /s/ and /z/ phonations, the s/z ratio was determined by dividing the maximum /s/ duration by the maximum /z/ duration.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 May 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Kutahya Health Sciences University Scientific Research Projects Coordination Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111650
- Sponsor's protocol ID
- PFM_PHONATION
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pelvic Floor Muscle Activity and Voice Acoustic Parameters in Young Adults
- ClinicalTrials.gov ID
- NCT07111650
- Acronym / sponsor ID
- PFM_PHONATION
- Conditions
- Healthy
- Keywords
- acoustic analysis, Electromyography, Pelvic floor muscle, phonation, Voice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Kutahya Health Sciences University Scientific Research Projects Coordination Unit
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Aug 2025 (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 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Being volunteer
- Age between 18- 40 years
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic floor muscle activity
Time frame: Baseline
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.
Acoustic Voice Analysis
Time frame: Baseline
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.
2 secondary outcomes
Maximum phonation time
Time frame: Baseline
s/z ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
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 9 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle activity (time frame: Baseline). The study lists 2 primary outcomes in all. 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 5 Aug 2026.