BC Women's Hospital Noise Pilot | NCT02651129

Studies
BC Women's Hospital Noise Pilot

NCT02651129

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Nov 17, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Noise Levels

Interventions

Noise measurement

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Dec 18, 2015

First Submission Date that Met QC Criteria

Jan 7, 2016

First Posted Date

Jan 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

Name	Class
University of British Columbia School of Population and Public Health	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete their tasks in a safe manner.

This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

Detailed Description

This is a pilot study that aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

The investigators want to quantify the amount of noise in BCW ORs in order to create a research question for a larger study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Noise measurement	Other	We will be measuring noise levels in the operating room

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
noise levels in decibels (dBs)	during cesarean section	1.5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BCW staff members
Presence in OR during Cesarean section
Willing to have a personal dosimeter pinned to hospital scrubs lapel

Exclusion Criteria:

- unable to read and understand English for the purpose of informed consent and perioperative communication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Operating room staff

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vit Gubka, MD FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada