NCT05636488

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 5, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 13, 2022

Last Update Submit

November 23, 2022

Conditions

Keywords

noise induced hearing lossoperatin room's noise

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

There is no intervention group in this study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Begüm Ne Gökdemir

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 5, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 5, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share