Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation Of Vestibular Functions and Balance in Edirne Band Musicians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915353
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Halit SELÇUK, Trakya University

Brief Summary:

It has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. The aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in Edirne Band musicians.

Twenty-two individuals working in the Edirne Band for at least 5 years and over 18 years of age and a control group of 22 individuals working at Trakya University and with similar sociodemographic characteristics to the experimental group were included. The socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the Activity-Specific Balance Confidence Scale to assess how they felt about the balance, and the Dizziness Handicap Inventory to determine the quality of life-related to dizziness. A 3D ultrasonic system was used to assess the static and dynamic balance of the individuals.


Condition or disease Intervention/treatment
Vestibular Disorder Other: No Intervention

Detailed Description:

Chronic exposure to intense noise causes temporary or permanent hearing loss. The effects of exposure to intense noise on the auditory system are well explained, but the number of studies that observes the effects of noise on the vestibular system is limited. It has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. The aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in Edirne Band musicians.

Twenty-two individuals working in the Edirne Band for at least 5 years and over 18 years of age who did not have a diagnosed vestibular disorder, no cervical vertebrae problem, no musculoskeletal system problems during the evaluation and a control group of 22 individuals working at Trakya University and with similar sociodemographic characteristics to the experimental group were included in the study. The socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the Activity-Specific Balance Confidence Scale to assess how they felt about the balance, and the Dizziness Handicap Inventory to determine the quality of life-related to dizziness. A 3D ultrasonic system was used to assess the static and dynamic balance of the individuals.

Layout table for study information
Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation Of Vestibular Functions and Balance in Edirne Band Musicians
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Experiment
No interventions
Other: No Intervention
No Intervention

Control
No interventions
Other: No Intervention
No Intervention




Primary Outcome Measures :
  1. Romberg Test [ Time Frame: 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test. ]
    Romberg test was assessed in the Zebris system. All measurements were performed in a quiet environment. For the Romberg test, the patient was asked to stay still for 60 seconds with his eyes closed, his feet contiguous, and his shoulders at 90 degrees flexion.

  2. Unterberger's Test [ Time Frame: 25 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test. ]
    Unterberger's test was assessed in the Zebris system. All measurements were performed in a quiet environment. For the Unterberger's test, subjects closed their eyes and began stepping in place for 60 seconds with shoulder at 90 degrees flexion, arms extended forward


Secondary Outcome Measures :
  1. Activities-Specific Balance Confidence Scale [ Time Frame: 5 minutes after obtaining socio-demographic information. ]
    ABC developed by Myers and Powel is a questionnaire based on evaluations of how confidently they can do 16 activities within and outside the house. Each activity scored between 0 (insecure) and 100 (completely confident). The total score (0-1600) is divided into 16 and the individual's ABC score is obtained. It has been shown to be reliable in patients with vestibular dysfunction. Higher values in ABC Scale represent a better outcome.

  2. Dizziness Handicap Inventory [ Time Frame: 10 minutes after obtaining socio-demographic information. ]
    DHI is a questionnaire that evaluates the quality of life and the disability caused by complaints related to dizziness and imbalance. DHI, developed by Jacobson and Newman, is a 25-item scale that identifies sensory and functional outcomes in patients with vestibular system problems, as well as factors affecting dizziness and balance disorder. Three subscales are aimed to determine the physical, sensory and functional effects of vestibular system diseases. The subscale scores which are considered as the limit for the determination of disability are 28 points for physical disability and 36 points for functional and sensory disability. Higher scores indicate that the person has more disability due to dizziness. According to the total score taken from the scale, people have divided into 3 groups; 0-30 points (mild disability), 31-60 points (moderate disability), 61-100 points (severe disability).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
22 males working as a musician in Edirne Band and a control group working in Trakya University with similar sociodemographic characteristics.
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Had at least for 5 years of experience at the Edirne Band
  • Volunteering to participate in the study

Exclusion Criteria:

  • Diagnosed vestibular disease
  • Cervical spine problems during the evaluation
  • Musculoskeletal problems during the evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915353


Locations
Layout table for location information
Turkey
Trakya University
Edirne, Turkey, 22000
Sponsors and Collaborators
Trakya University
Layout table for additonal information
Responsible Party: Halit SELÇUK, Research Assisstant, Trakya University
ClinicalTrials.gov Identifier: NCT03915353    
Other Study ID Numbers: 2017/234
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halit SELÇUK, Trakya University:
Noise
Balance
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases