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CompletedNCT03915353Updated Apr 16, 2019

Evaluation Of Vestibular Functions and Balance in Edirne Band Musicians

An observational study in Vestibular Disorder, sponsored by Trakya University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by Trakya University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
44
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Vestibular Disorder

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Keywords

  • Noise
  • Balance
  • Quality of Life
03

In context

Vestibular Diseases

175 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

This study's enrollment of 44 is below the median of 59 across 36 observational studies indexed under Vestibular Diseases.

Browse Vestibular Diseases studies →

Lead sponsor

Trakya University is the lead sponsor of 154 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosed vestibular disease
  • Cervical spine problems during the evaluation
  • Musculoskeletal problems during the evaluation
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • Experiment

    No interventions

    Other: No Intervention

  • Control

    No interventions

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. Romberg 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.

    Time frame: 20 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.

  2. Unterberger's 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

    Time frame: 25 minutes after obtaining socio-demographic information, participants who met the inclusion criteria included in the test.

Secondary outcomes

  1. Activities-Specific Balance Confidence Scale

    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.

    Time frame: 5 minutes after obtaining socio-demographic information.

  2. Dizziness Handicap Inventory

    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).

    Time frame: 10 minutes after obtaining socio-demographic information.

07

Study locations

1 site
  • Trakya University
    Edirne, 22000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03915353
Lead sponsor
Trakya University
Responsible party
Halit SELÇUK (Research Assisstant, Trakya University) — Principal investigator
First posted
Apr 16, 2019
Start date
Mar 1, 2017
Primary completion
Apr 15, 2018
Completion
Jun 30, 2018
Last update
Apr 16, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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