Noise ExposureNCT04204785
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
A study testing Noise Reduction Education in people with Noise Exposure and Surgery, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Surgery, Patient Satisfaction
- What is being tested?
- Noise Reduction Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion Criteria:
- Age 18 or greater
- Elective, non-cardiac operating room procedure with general anesthesia as the primary mode of anesthesia
Patient Exclusion Criteria:
- 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
Anesthesiologist Inclusion Criteria:
- Working in the eligible ORs with eligible patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noise in the Operating Room at Induction and Patient Satisfaction and Experience (NOISE) Study
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.
Read more
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.
Read the detailed description
1.0 BACKGROUND: Noise in the operating room (OR) is common whether it be related to surgical equipment, anesthetic monitors, or conversations between health care providers and patients regarding the procedure or patient status. In particular, certain periods can be louder than others, such as during induction and emergence of anesthesia, with preparation and conversations as the major sources of noise during induction. Noise at this time has been shown to lead to deleterious patient outcomes, as staff are unable to hear subtle or even significant changes in monitors, or have difficulty focusing during a critical time of induction. It has also been demonstrated that poor postoperative outcomes in pediatric patients and increase in stress levels in surgeons. While anecdotal, what is not elucidated in the literature is whether or not excess noise during induction affects a patient's perioperative satisfaction. Induction is often a distressing time for patients and extraneous noise may have a significant impact on their overall experience. This study is the first to explore the impact of noise at induction on patient satisfaction investigate whether a reduction in noise on induction can improve patient satisfaction. A secondary outcome is to achieve a decrease in noise level in non-cardiac operating rooms at this facility, promoting the concept of a 'sterile cockpit' (silence during induction) as borrowed from the aviation industry.
2.0 JUSTIFICATION: Studies have demonstrated that excessive noise in the operating room can be associated with critical error. Additionally, it has been shown that for Anesthesiologists' excessive noise can lead to increased. However, the effects of noise in the OR at the time of induction on patient experience remains unclear. While other validated questionnaires regarding patient satisfaction during the perioperative period have been established, these do not include questions regarding noise levels. Thus, this study will be the first to examine how noise during induction will affect patients' perioperative experience.
This tertiary care facility, St. Paul's Hospital, located in Vancouver, British Columbia, does not have a specific protocol or mandate with respect to noise in the operating room at any time. The recommended decibel levels in OR's is <45 decibels.
3.0 STUDY PURPOSE:
The purpose of this study is to:
- Collect data regarding noise levels in the OR at the time of induction
- Collect patient satisfaction survey during phase 1
- Complete noise-reduction strategies (phase 2) to reduce levels of noise in the operating room during the time of induction
- Repeat patient satisfaction survey during phase 3 to determine if patient satisfaction improves with reduction of noise during induction
- Collect data on Anesthesiologist satisfaction survey during phase 1
- Repeat anesthesiologist satisfaction survey during phase 3 to determine if this improves with reduction of noise during induction
4.0 HYPOTHESIS:
The null hypothesis is:
- There is no improvement in patient satisfaction with the reduction of noise at the time of induction.
5.0 OBJECTIVES:
The objectives of this study are to:
- Collect preliminary data regarding noise levels in the OR during induction
- Determine if noise-reduction strategies and education during induction decreases noise levels in the operating room
- Determine if noise-reduction strategies and education improve patient satisfaction in the perioperative period
- Determine if noise-reduction strategies and education improve Anesthesiologist satisfaction during induction
6.0 METHODS \& STATISTICS: 6.1 Research Design Overview: Questionnaire Study
This study will take place over three phases.
Phase I:
Measure baseline characteristics of designated non-cardiac, elective operating rooms requiring a general anesthetic as primary mode of anesthesia. This will act as the control group for the study. Data collection will be performed by the attending Anesthesiologist using a portable decibel-meter and a smart phone with a decibel-meter application placed by the patient's head during induction. The Anesthesiologist will use the devices to determine a baseline noise level (maximum and mean decibel levels) in the OR from the time that patient enters the OR to when the patient is successfully intubated. The Anesthesiologist taking the measurement will conceal the devices from the others in the OR (including OR staff and patients). The investigators have received approval from the OR to use this concealed device. The same Anesthesiologist will then fill out a questionnaire regarding patient demographics (e.g. type of procedure, age, anxiety, significant hearing impairment, cognitive impairment) and observed noise in the operating room.
Patient participants will be recruited post-operatively in the postoperative care unit (PACU) and Surgical Day Care (SDC) if they are being discharged home on the same day or on the post-surgical wards if they are being admitted to hospital after surgery. The investigators will recruit patient participants post-operatively so as not to bias their experiences pre-operatively. They will be approached by the perioperative Anesthesiologist when deemed of appropriate mental capacity, to ask if they are willing to hear about the study. If they agree, the perioperative physician will alert a study team member of the eligible patient and they will approach the patient to discuss the study and seek consent. The recruiter will not be involved in the patient's direct care as to ensure patients that their care will not be influenced by whether they decide to participate or not. When recruited, they will complete an anonymous, self-administered questionnaire that will assess their satisfaction or dissatisfaction of care, using a Likert scale questionnaire designed specifically for extraneous noise during the time of induction. A Likert scale questionnaire is used as this has been most validated for perioperative satisfaction in multiple validated questionnaires.
Phase II:
This involves an educational intervention in the form of a didactic teaching session for the surgical teams, Anesthesiologists, Anesthesia Assistants, Perioperative Nurses, and Patient Care Aids The education will be focused on the importance of noise reduction during induction, specifically highlighting its potential positive effects on improving patient outcomes (and potentially patient satisfaction) and impact on surgical teams and Anesthesiologists. This will include formal presentations for each group of OR staff and daily prompts prior to the start of the day slate.
Phase III:
This will be conducted following education of perioperative health care professionals. Exactly the same as phase I, but after education. This involves repeating participant recruitment and data collection, with the Anesthesiologist completing the questionnaire and collecting noise level data, as well as patient participants completing self-administered questionnaires as a repeat of the protocol described above in phase I.
- Conditions
- Noise Exposure, Surgery, Patient Satisfaction, Anesthesia
- Being tested
- Noise Reduction Education
- Keywords
- Operating Room Environment, Noise, General Anesthesia
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise Reduction EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Noise Reduction Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 survey in the pre-education and post-education phases. The responses were a combination of yes/no responses, and likert scales. The 5-point likert scale response options ranged from: "Not At All, A Little Bit, Moderately, Quite A Bit, Extremely". Responses will be compared between groups by question.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start5 Sep 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-Post Education Survey study
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trina Montemurro, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204785
- Sponsor's protocol ID
- H19-01798
- Status last verified
- Jun 2020
- First submitted
- 17 Dec 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.
PubMed 24878496Ginsberg 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.
PubMed 23107015Hasfeldt 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.
PubMed 21126668Liu 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.
PubMed 10960202Hogan 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.
PubMed 26411830Murthy 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.
PubMed 7553997Engelmann 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.
PubMed 24394594Barnett 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.
PubMed 23669268Auquier 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.
PubMed 15915023Caljouw 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.
PubMed 18337271Jlala 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.
PubMed 22915869Mui 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.
PubMed 21455058Yu 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.
PubMed 35014000
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise in the Operating Room at Induction and Patient Satisfaction and Experience (NOISE) Study
- ClinicalTrials.gov ID
- NCT04204785
- Acronym / sponsor ID
- H19-01798
- Conditions
- Noise Exposure, Surgery, Patient Satisfaction, Anesthesia
- Keywords
- Operating Room Environment, Noise, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
1.0 BACKGROUND: Noise in the operating room (OR) is common whether it be related to surgical equipment, anesthetic monitors, or conversations between health care providers and patients regarding the procedure or patient status. In particular, certain periods can be louder than others, such as during induction and emergence of anesthesia, with preparation and conversations as the major sources of noise during induction. Noise at this time has been shown to lead to deleterious patient outcomes, as staff are unable to hear subtle or even significant changes in monitors, or have difficulty focusing during a critical time of induction. It has also been demonstrated that poor postoperative outcomes in pediatric patients and increase in stress levels in surgeons. While anecdotal, what is not elucidated in the literature is whether or not excess noise during induction affects a patient's perioperative satisfaction. Induction is often a distressing time for patients and extraneous noise may have a significant impact on their overall experience. This study is the first to explore the impact of noise at induction on patient satisfaction investigate whether a reduction in noise on induction can improve patient satisfaction. A secondary outcome is to achieve a decrease in noise level in non-cardiac operating rooms at this facility, promoting the concept of a 'sterile cockpit' (silence during induction) as borrowed from the aviation industry.
2.0 JUSTIFICATION: Studies have demonstrated that excessive noise in the operating room can be associated with critical error. Additionally, it has been shown that for Anesthesiologists' excessive noise can lead to increased. However, the effects of noise in the OR at the time of induction on patient experience remains unclear. While other validated questionnaires regarding patient satisfaction during the perioperative period have been established, these do not include questions regarding noise levels. Thus, this study will be the first to examine how noise during induction will affect patients' perioperative experience.
This tertiary care facility, St. Paul's Hospital, located in Vancouver, British Columbia, does not have a specific protocol or mandate with respect to noise in the operating room at any time. The recommended decibel levels in OR's is <45 decibels.
3.0 STUDY PURPOSE:
The purpose of this study is to:
- Collect data regarding noise levels in the OR at the time of induction
- Collect patient satisfaction survey during phase 1
- Complete noise-reduction strategies (phase 2) to reduce levels of noise in the operating room during the time of induction
- Repeat patient satisfaction survey during phase 3 to determine if patient satisfaction improves with reduction of noise during induction
- Collect data on Anesthesiologist satisfaction survey during phase 1
- Repeat anesthesiologist satisfaction survey during phase 3 to determine if this improves with reduction of noise during induction
4.0 HYPOTHESIS:
The null hypothesis is:
- There is no improvement in patient satisfaction with the reduction of noise at the time of induction.
5.0 OBJECTIVES:
The objectives of this study are to:
- Collect preliminary data regarding noise levels in the OR during induction
- Determine if noise-reduction strategies and education during induction decreases noise levels in the operating room
- Determine if noise-reduction strategies and education improve patient satisfaction in the perioperative period
- Determine if noise-reduction strategies and education improve Anesthesiologist satisfaction during induction
6.0 METHODS \& STATISTICS: 6.1 Research Design Overview: Questionnaire Study
This study will take place over three phases.
Phase I:
Measure baseline characteristics of designated non-cardiac, elective operating rooms requiring a general anesthetic as primary mode of anesthesia. This will act as the control group for the study. Data collection will be performed by the attending Anesthesiologist using a portable decibel-meter and a smart phone with a decibel-meter application placed by the patient's head during induction. The Anesthesiologist will use the devices to determine a baseline noise level (maximum and mean decibel levels) in the OR from the time that patient enters the OR to when the patient is successfully intubated. The Anesthesiologist taking the measurement will conceal the devices from the others in the OR (including OR staff and patients). The investigators have received approval from the OR to use this concealed device. The same Anesthesiologist will then fill out a questionnaire regarding patient demographics (e.g. type of procedure, age, anxiety, significant hearing impairment, cognitive impairment) and observed noise in the operating room.
Patient participants will be recruited post-operatively in the postoperative care unit (PACU) and Surgical Day Care (SDC) if they are being discharged home on the same day or on the post-surgical wards if they are being admitted to hospital after surgery. The investigators will recruit patient participants post-operatively so as not to bias their experiences pre-operatively. They will be approached by the perioperative Anesthesiologist when deemed of appropriate mental capacity, to ask if they are willing to hear about the study. If they agree, the perioperative physician will alert a study team member of the eligible patient and they will approach the patient to discuss the study and seek consent. The recruiter will not be involved in the patient's direct care as to ensure patients that their care will not be influenced by whether they decide to participate or not. When recruited, they will complete an anonymous, self-administered questionnaire that will assess their satisfaction or dissatisfaction of care, using a Likert scale questionnaire designed specifically for extraneous noise during the time of induction. A Likert scale questionnaire is used as this has been most validated for perioperative satisfaction in multiple validated questionnaires.
Phase II:
This involves an educational intervention in the form of a didactic teaching session for the surgical teams, Anesthesiologists, Anesthesia Assistants, Perioperative Nurses, and Patient Care Aids The education will be focused on the importance of noise reduction during induction, specifically highlighting its potential positive effects on improving patient outcomes (and potentially patient satisfaction) and impact on surgical teams and Anesthesiologists. This will include formal presentations for each group of OR staff and daily prompts prior to the start of the day slate.
Phase III:
This will be conducted following education of perioperative health care professionals. Exactly the same as phase I, but after education. This involves repeating participant recruitment and data collection, with the Anesthesiologist completing the questionnaire and collecting noise level data, as well as patient participants completing self-administered questionnaires as a repeat of the protocol described above in phase I.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-Post Education Survey study
| Arm | Type | Receives |
|---|---|---|
| Pre-Education | No intervention | –Patient and Anesthesiologist participants completing surveys prior to OR staff education sessions. |
| Post-Education | Experimental | Behavioral: Noise Reduction EducationPatient and Anesthesiologist participants completing surveys after OR staff education sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noise Reduction EducationOR 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. | Behavioural | Post-Education |
Primary outcome
Change in Maximum Noise Levels Pre-/Post-Education
Time frame: 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 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.
Change in Average Noise Levels Pre-/Post-Education
Time frame: 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/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.
Patient Satisfaction Pre-/Post-Education
Time frame: 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.
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.
1 secondary outcome
Anesthesiologist Satisfaction Pre-/Post-Education
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 24878496Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.
- Background: PubMed 23107015Ginsberg 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.
- Background: PubMed 21126668Hasfeldt 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.
- Background: PubMed 10960202Liu 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.
- Background: PubMed 26411830Hogan 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.
- Background: PubMed 7553997Murthy 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.
- Background: PubMed 24394594Engelmann 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.
- Background: PubMed 23669268Barnett 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.
- Background: PubMed 15915023Auquier 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.
- Background: PubMed 18337271Caljouw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noise Reduction Education in people with Noise Exposure and Surgery, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Noise Levels Pre-/Post-Education (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204785, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.