Determination of the Effects of Noise Level in the Operating Room

Noise Induced Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05636488
• Other study ID #: 2022-07/1932
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Baskent University
• Contact: Begüm Ne Gökdemir
• Phone: +905389598290
• Email: begokdemir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise Induced Hearing Loss
• Noise; Adverse Effect

Intervention

Other:
• No intervention
There is no intervention group in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing effect of noise level on fatigue with questionnaire	A quieter environment can be created if noise level can be shown to cause fatigue in work performance.	postoperative 24 hours
Primary	assessing effect of noise level on anxiety with questionnaire	A quieter environment can be created if noise level can be shown to cause anxiety in work performance.	postoperative 24 hours