NCT04638296

Brief Summary

Background: Noise in operating rooms (ORs) during surgery may affect OR personnel and pose a threat to patient safety. The sources of noise vary depending on the operation. We aimed to study how OR staff perceived noise, whether music was considered noise and what its perceived effects were. Methods: Surgeons, anesthesiologists, residents, and nurses were interviewed. IPads were placed in the ORs to gather noise level data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 9, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

MusicOperating RoomNoiseSurgery

Outcome Measures

Primary Outcomes (2)

  • Perceptions on Noise in the OR

    Via an interview participants were asked about their perception on noise in the OR, the sources of noise and how it affected their performance, concentration and communication.

    1 year

  • Perceptions on Music in the OR

    Via an interview participants were asked about their perception on music in the OR, the sources of noise and how it affected their performance, concentration and communication.

    1 year

Study Arms (2)

Physicians

surgeons, anesthesiologists, and surgical residents

Other: Interviews

Nurses

OR Nurses

Other: Interviews

Interventions

The investigators designed 3 versions of the semi structured interview guide for each of the surgeons/anesthesiologists (Appendix A.1), residents (Appendix A.2) and nurses (Appendix A. 3). All versions were subdivided into 3 general categories: 1) participant demographics such as participant's age, years of experience, specialty, years of employment at the institution 2) participant's perceptions of noise in the OR, what they considered as sources of noise, the loudness level, whether they thought this impacted their concentration, performance, communication, whether this was distracting or helpful in different stages of the operation, and 3) perceptions on music.

NursesPhysicians

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All OR staff were eligible for recruitment, including surgeons, anesthesiologists, residents and nurses. There were no exclusion criteria per se; however, the interview had to be conducted on the day the participant was involved in a surgical operation.

All OR staff were eligible for recruitment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Pediatrics and Pediatric Critical Care

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 20, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations