NCT03915353

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

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

March 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

April 10, 2019

Last Update Submit

April 12, 2019

Conditions

Keywords

NoiseBalanceQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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

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

Secondary Outcomes (2)

  • Activities-Specific Balance Confidence Scale

    5 minutes after obtaining socio-demographic information.

  • Dizziness Handicap Inventory

    10 minutes after obtaining socio-demographic information.

Study Arms (2)

Experiment

No interventions

Other: No Intervention

Control

No interventions

Other: No Intervention

Interventions

No Intervention

ControlExperiment

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

March 1, 2017

Primary Completion

April 15, 2018

Study Completion

June 30, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations