Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 4:44 PM
Study NCT ID:
NCT07111650
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation of Pelvic Floor Muscle and Phonation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle activity', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Acoustic Voice Analysis', 'timeFrame': 'Baseline', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Maximum phonation time', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 's/z ratio', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acoustic analysis', 'Electromyography', 'Pelvic floor muscle', 'phonation', 'Voice'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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 .\n\nPelvic 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.\n\nVoice 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being volunteer\n* Age between 18- 40 years\n\nExclusion Criteria:\n\n1. urological, gynecological, respiratory, or vocal disorders,\n2. cognitive or perceptual problems,\n3. being pregnant,\n4. being in the premenstrual or menstrual phase on the evaluation day,\n5. having allergies, cold, or flu on the evaluation day,\n6. perineal sensitivity,\n7. any surgery in the abdominal, stomach, respiratory, laryngeal, and/or head and neck regions,\n8. vocal complaints for at least 15 days,\n9. hearing complaints.'}, 'identificationModule': {'nctId': 'NCT07111650', 'briefTitle': 'Relation of Pelvic Floor Muscle and Phonation', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Relationship Between Pelvic Floor Muscle Activity and Voice Acoustic Parameters in Young Adults', 'orgStudyIdInfo': {'id': 'PFM_PHONATION'}}, 'contactsLocationsModule': {'locations': [{'zip': '43020', 'city': 'Kütahya', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Kutahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}, {'zip': '43020', 'city': 'Kütahya', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Kutahya Helath Sciences University- Health Sciences Faculty', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scientific Research Projects Coordination Unit', 'class': 'AMBIG'}], 'responsibleParty': {'type': 'SPONSOR'}}}}