Noise in the OR at Induction: Patient and Anesthesiologists Perceptions

NCT04204785 | Completed

• 1 other identifier: H19-01798
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Noise in the operating room is common and often unavoidable, but there is mixed evidence of its impact. Previous research has suggested that excessive noise at the time when a patient is being 'put to sleep' may lead to care teams missing changes in monitors, having difficulties focusing or increasing stress. However, it is unknown ifs noise at this time affects the patient's satisfaction with the overall surgical experience. The investigators are conducting a survey study to evaluate patients' and anesthesiologists' overall satisfaction at the time of induction, before and after an education program promoting reducing noise in the Operating Room. Study Purpose: The purpose of this study is to investigate how noise levels that the time of induction in the OR (operating room) effect patient and anesthesiologists' satisfaction with the overall surgical experience. Hypothesis: The null hypothesis is that there is no improvement in patient satisfaction with the reduction of noise at the time of induction. Study Population: The Investigators will be including two study populations: patients age 19 or older undergoing elective, non-cardiac surgery with general anesthesia as the primary mode of anesthesia, and; Anesthesiologists working in these rooms. Research Method: This will be a pre/post survey study of patients and Anesthesiologists perspectives of noise in the OR. The investigators will survey participants before and after an educational intervention for OR staff.

Conditions

Noise Exposure; Surgery; Patient Satisfaction; Anesthesia

Keywords

Operating Room Environment; Noise; General Anesthesia

Outcome Measures

Primary Outcomes (3)

• Change in Maximum Noise Levels Pre-/Post-Education

  Change in maximum noise levels from pre-education to post-education. Maximum noise levels are measured from the time a patient enters the Operating Room (OR) to the time when the patient is intubated (approximately 5-20 minutes) using an I-phone application (app). The app measures decibel levels and the results were recorded by the anesthesiologist or research assistant.

  The time from patient entering the OR to patient being fully intubated ranged from approximately 5 to 20 minutes. The change is measured between the pre- and post-education phases of the study.

• Change in Average Noise Levels Pre-/Post-Education

  Change in average/mean noise levels from pre-education to post-education. Mean noise levels are measured from the time a patient enters the Operating Room (OR) to the time when the patient is intubated (approximately 5-20 minutes) using an I-phone application (app). The app measures decibel levels and the results were recorded by the anesthesiologist or research assistant.

  The time from patient entering the OR to patient being fully intubated ranged from approximately 5 to 20 minutes. The change is measured between the pre- and post-education phases of the study.

• Patient Satisfaction Pre-/Post-Education

  Patients from the pre-education and post-education groups completed the same satisfaction rating survey. The responses were a combination of yes/no responses and likert scales. The 5-point likert scale response options ranged from: "Strongly disagree, Disagree, Not Sure, Agree, Strongly Agree" and "Not At All, A Little Bit, Moderately, Quite A Bit, Extremely". Responses will be compared between groups by question.

  Patients completed the same surveys in phase 1(pre-education) and phase 3 (post-education). The education was done within a 2 month period after the first phase and before the third phase.

Secondary Outcomes (1)

• Anesthesiologist Satisfaction Pre-/Post-Education

  Anesthesiologists completed the same surveys in phase 1(pre-education) and phase 3 (post-education). The education was done within a 2 month period after the first phase and before the third phase.

Study Arms (2)

Pre-Education

NO INTERVENTION

Patient and Anesthesiologist participants completing surveys prior to OR staff education sessions.

Post-Education

EXPERIMENTAL

Patient and Anesthesiologist participants completing surveys after OR staff education sessions.

Behavioral: Noise Reduction Education

Interventions

Noise Reduction Education BEHAVIORAL

OR staff will be offered education regarding the importance of minimizing noise in the OR. There will also be reminder signs and posters for the duration of the post-education period.

Post-Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• Elective, non-cardiac operating room procedure with general anesthesia as the primary mode of anesthesia

You may not qualify if:

• Age \<19
• Non-elective surgery
• Patients who do not receive General Anesthesia
• Cardiac surgery
• Significant hearing impairment (self-reported)
• Significant cognitive impairment
• Surgeries less than 20 minutes in length
• Medically unstable postoperatively
• Anesthesiologist Participants
• Working in the eligible ORs with eligible patients

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (13)

• Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.

  PMID: 24878496 BACKGROUND

• Ginsberg SH, Pantin E, Kraidin J, Solina A, Panjwani S, Yang G. Noise levels in modern operating rooms during surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):528-30. doi: 10.1053/j.jvca.2012.09.001. Epub 2012 Oct 27.

  PMID: 23107015 BACKGROUND

• Hasfeldt D, Laerkner E, Birkelund R. Noise in the operating room--what do we know? A review of the literature. J Perianesth Nurs. 2010 Dec;25(6):380-6. doi: 10.1016/j.jopan.2010.10.001.

  PMID: 21126668 BACKGROUND

• Liu EH, Tan S. Patients' perception of sound levels in the surgical suite. J Clin Anesth. 2000 Jun;12(4):298-302. doi: 10.1016/s0952-8180(00)00155-0.

  PMID: 10960202 BACKGROUND

• Hogan LJ, Harvey RL. Creating a Culture of Safety by Reducing Noise Levels in the OR. AORN J. 2015 Oct;102(4):410.e1-7. doi: 10.1016/j.aorn.2015.08.005.

  PMID: 26411830 BACKGROUND

• Murthy VS, Malhotra SK, Bala I, Raghunathan M. Detrimental effects of noise on anaesthetists. Can J Anaesth. 1995 Jul;42(7):608-11. doi: 10.1007/BF03011878.

  PMID: 7553997 BACKGROUND

• Engelmann CR, Neis JP, Kirschbaum C, Grote G, Ure BM. A noise-reduction program in a pediatric operation theatre is associated with surgeon's benefits and a reduced rate of complications: a prospective controlled clinical trial. Ann Surg. 2014 May;259(5):1025-33. doi: 10.1097/SLA.0000000000000253.

  PMID: 24394594 BACKGROUND

• Barnett SF, Alagar RK, Grocott MP, Giannaris S, Dick JR, Moonesinghe SR. Patient-satisfaction measures in anesthesia: qualitative systematic review. Anesthesiology. 2013 Aug;119(2):452-78. doi: 10.1097/ALN.0b013e3182976014.

  PMID: 23669268 BACKGROUND

• Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.

  PMID: 15915023 BACKGROUND

• Caljouw MA, van Beuzekom M, Boer F. Patient's satisfaction with perioperative care: development, validation, and application of a questionnaire. Br J Anaesth. 2008 May;100(5):637-44. doi: 10.1093/bja/aen034. Epub 2008 Mar 12.

  PMID: 18337271 BACKGROUND

• Jlala HA, Caljouw MA, Bedforth NM, Hardman JG. Patient satisfaction with perioperative care among patients having orthopedic surgery in a university hospital. Local Reg Anesth. 2010;3:49-55. doi: 10.2147/lra.s11381. Epub 2010 Jul 28.

  PMID: 22915869 BACKGROUND

• Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.

  PMID: 21455058 BACKGROUND

• Yu CV, Foglia J, Yen P, Montemurro T, Schwarz SKW, MacDonell SY. Noise in the operating room during induction of anesthesia: impact of a quality improvement initiative. Can J Anaesth. 2022 Apr;69(4):494-503. doi: 10.1007/s12630-021-02187-9. Epub 2022 Jan 10.

  PMID: 35014000 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants are not randomly assigned to a group.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Pre-Post Education Survey study

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: September 5, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

CA (1)