Determination of the Effects of Noise Level in the Operating Room

November 23, 2022 updated by: Begüm Nemika Gökdemir, Baskent University

Determination of the Effects of Noise Level in the Operating Room on the Anesthesiologist, Patient, and Environment During the Induction Phase and Investigation of the Effect of Staff Training

The goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There are many factors that can negatively affect surgical performance in operating rooms. Noise is the most striking of these factors. Excessive noise can cause hearing loss, cognitive dysfunction, anxiety, stress-induced increases in cortisol levels, and an increased risk of cardiovascular disease. Noise can have negative effects on concentration and performance. At the same time, workplace noise is one of the most important causes of fatigue. One of the anesthesia phases where the sound level reaches the highest levels is the induction phase. With this study, the investigators want to examine the effects on the anesthesia team, the patient and the environment by measuring the noise levels during the induction period, and then train the operating room personnel to examine the effects on this issue. The investigators aim to raise awareness about the development of procedures and training programs for operating room personnel.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients over the age of 18 without hearing loss who will undergo elective surgery under general anesthesia

Description

Inclusion Criteria:

  • patients over the age of 18,

    • Elective cases to be taken under general anesthesia,
    • Those who do not have a psychiatric disease,
    • Patients without hearing loss

Exclusion Criteria:

  • patients under the age of 18
  • Patients who have psychiatric disease
  • Patients who has hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessing effect of noise level on fatigue with questionnaire
Time Frame: postoperative 24 hours
A quieter environment can be created if noise level can be shown to cause fatigue in work performance.
postoperative 24 hours
assessing effect of noise level on anxiety with questionnaire
Time Frame: postoperative 24 hours
A quieter environment can be created if noise level can be shown to cause anxiety in work performance.
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-07/1932

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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