Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2021-11-01
2023-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery
NCT06666686
The Effect of Music on Postoperative Anxiety
NCT06764407
Effect of Progressive Muscle Relaxation on Fear of Falling, Pain, and Anxiety in Arthroplasty Patients
NCT07098390
Pressurized Cold Application for Patients Total Knee Prosthesis Surgery
NCT05233423
The Effect of Video Education on Anesthesia Choice
NCT07246798
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Today, it is reported that noise pollution in hospitals has increased exponentially compared to previous years . It is reported that the noise is especially at high levels in the operating room units of hospitals and frequently exceeds both the 30 dBA (Decibel A) threshold determined by the World Health Organization and the American Occupational Safety and Health Administration standard. When we look at the studies in which the environmental noise in the operating room environment is examined, it is seen that the noise level varies between 80 and 119 dBA. These noise ranges are determined for both patient and employee health. is beyond the limits.
The noise that patients are exposed to in operating rooms can be caused by both healthcare workers and operating room equipment. Perioperative Nurses Association (AORN) created the "AORN Guide on Managing Distraction and Noise During Perioperative Patient Care" in 2014 to draw attention to the problem of loud noise in the operating room. According to this guideline, updated in 2020, noise is a risky situation that interrupts intraoperative care. For this reason, it is reported that noise should be prevented with an inter-team approach in order for effective care and treatment to continue. In the AORN report, it is reported that among the sources of noise are monitors, ventilators, air conditioning systems, telephones, pagers, surgical equipment, anesthesia devices, conversations within the team, and loud music. The methods used in surgeries and the choice of surgical instruments also affect noise levels. For this reason, it can be said that noise levels may change in surgeries performed with different instruments in different parts of the body. Especially in knee and hip replacement surgeries, when tools such as oscillator saws, hammers and surgical drills, which are used to shape the joint and replace the joint prosthesis, are used during the operation, it creates a higher noise compared to other surgeries. Simpson reported in their study that the noise level of the instruments used during knee and hip replacement surgery increased up to 105 decibels. While this noise level is equivalent to the noise heard while waiting next to a working helicopter, it is well above the thresholds recommended by NIOSH, OSHA and WHO.
It is reported that the negative effects of environmental noise during surgery on patients are controlled with sedative agents given to the patient during surgery. In addition, it is known that patients are made to listen to music to reduce the effect of environmental noise and to relax the patient. When the studies are examined, it is seen that there are limitations in both methods used. Listening to louder music so that the high-frequency sounds that occur during prosthetic surgeries are not heard by the patients can be another source of anxiety for the patients. Sedative opioid agents given to calm patients pose various risks, such as respiratory depression, death or permanent brain damage, and this is defined as a patient safety problem in the literature. Since the degeneration (arthrosis) of the knee joint will occur over the years, the patient population in need of prosthesis is generally geriatric. This situation causes the adverse risks of sedation on elderly patients to be much higher. The operating room nurse should take the necessary measures to reduce the stress, fear and anxiety of the patient who will undergo surgery. It is one of the independent roles of the nurse to ensure that non-pharmacological methods are used instead of pharmacological sedative agents applied to the patient.
Active noise control is one of the methods in which the noise is controlled with headphones that produce a sound in phase opposite to the environmental noise, and passive noise control is one of the methods in which the noise is controlled by the isolation method. Music therapy, on the other hand, lowers the blood pressure and pulse of the patients, regulates the respiratory rate and increases the oxygen saturation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active noise cancelling
Patients corresponding to the number 1 blocks in the randomization table according to the order of surgery were included in the active noise control group. Preoperative care of the patients was performed by clinical nurses. After transferring to the operating room and performing spinal anesthesia, the active noise control headset (Sony WH1000xm4) was placed on the patient's head. The active noise control feature of the headset was turned on and it was not removed until the dressing of the patient was closed at the end of the operation. In this group, the vital signs of the patients were followed up during the surgery. At the end of each surgery, the researcher disinfected the earplugs with an antiseptic solution containing 2% chlorhexidine. In addition, the battery level of the headset was checked and charged by the researcher when necessary. This ensures that the headset is ready for the next patient.
Active noise cancelling
During the operation, active noise canceling device (Sony wh100xm3) will be applied to the patients in Group-1 after spinal anesthesia is applied and will not be removed until the operation is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Passive noise cancelling
The patients corresponding to the number 2 blocks in the randomization table according to the order of operation were included in the passive noise control group. Preoperative care of the patients was performed by clinical nurses. After transferring to the operating room and performing spinal anesthesia, passive noise control headset (3M Peltor Optime II) was placed on the patient's head. The earphone was not removed until the dressing of the patient was closed at the end of the surgery. In this group, the vital signs of the patients were followed up during the surgery. At the end of each operation, the earplugs were disinfected by the researcher with an antiseptic solution containing 2% chlorhexidine and prepared for the next patient.
Passive noice cancelling
During the operation, passive noise canceling device (3M Peltor X5a) will be applied to the patients in Group-2 after spinal anesthesia is applied and will not be removed until the operation is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Active noise cancelling with music therapy
Patients corresponding to blocks numbered 3 in the randomization table according to the order of surgery were included in the music therapy group. Preoperative care of the patients was performed by clinical nurses. After transferring to the operating room and performing spinal anesthesia, the headset (Sony WH1000xm4) was positioned on the patient's head as shown in Figure 3.7-5 (A). iPod Touch 7th Generation music player with Spotify mobile application was used for music application. The connection between the headset and the music player was provided via Bluetooth. Music chosen by the patient; Active noise control was turned on and the patient was listened to until the dressing was removed at the end of the operation. The vital signs of the patient during the operation were followed up. In addition, the battery level of the headset was checked and charged by the researcher when necessary. This ensures that the headset is ready for the next patient.
Active noise cancelling with music therapy
The patients in Group-3 will be given music therapy with an active noise canceling tool (Sony wh100xm3) during the surgery. The music that the patient will listen to will be left to the patient's preference. Music therapy with an active noise canceling device will be applied after spinal anesthesia is applied and will not be removed until the surgery is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Control group
Patients corresponding to blocks numbered 0 in the randomization table according to the order of surgery were included in the control group. The patients, whose preoperative care was performed by clinical nurses, were transferred to the operating room and spinal anesthesia was administered. No intervention was made in this group during the surgery. The vital signs of the patients were followed up during the operation.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active noise cancelling
During the operation, active noise canceling device (Sony wh100xm3) will be applied to the patients in Group-1 after spinal anesthesia is applied and will not be removed until the operation is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Passive noice cancelling
During the operation, passive noise canceling device (3M Peltor X5a) will be applied to the patients in Group-2 after spinal anesthesia is applied and will not be removed until the operation is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Active noise cancelling with music therapy
The patients in Group-3 will be given music therapy with an active noise canceling tool (Sony wh100xm3) during the surgery. The music that the patient will listen to will be left to the patient's preference. Music therapy with an active noise canceling device will be applied after spinal anesthesia is applied and will not be removed until the surgery is completed. At the end of the surgery, the trait anxiety scale will be administered to the patients and the VAS pain scale will be administered at the 1st Hour, 8th Hour and 24th Hour. The obtained data will be recorded.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* To participate in the research voluntarily,
* To be able to read and write Turkish,
* American Association of Anesthesiologists (ASA) classification I or II,
* To have total knee arthroplasty surgery due to joint degeneration (gonarthrosis),
* Not using any medication that will affect anxiety,
* To be problem-free in terms of sensory perceptions and communication,
* The patient is conscious, oriented and cooperative.
Exclusion Criteria
* Presence of diagnosed cancer in the patient.
* Being diagnosed with any psychiatric illness,
* Having previously undergone arthroplasty surgery (Revision arthroplasty).
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bezmialem Vakif University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deniz Öztekin, Professor
Role: STUDY_DIRECTOR
Doğuş University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bezmialem University
Istanbul, Fatih, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.
Tran BW, Nowrouz MY, Dhillon SK, Xie KK, Breslin KM, Golladay GJ. The Impact of Music and Noise-Cancellation on Sedation Requirements During Total Knee Replacement: A Randomized Controlled Trial. Geriatr Orthop Surg Rehabil. 2020 Mar 4;11:2151459320910844. doi: 10.1177/2151459320910844. eCollection 2020.
Liu M, Yi C, Yin F, Dai Y. Noise in the outpatient operating room. Gland Surg. 2020 Apr;9(2):380-384. doi: 10.21037/gs.2020.04.09.
Yeganeh S, Torabizadeh C, Bahmani T, Molazem Z, Doust HY, Dehnavi SD. Examining the views of operating room nurses and physicians on the relationship between professional values and professional communication. BMC Nurs. 2022 Jan 14;21(1):17. doi: 10.1186/s12912-021-00778-x.
Wang X, Zeng L, Li G, Xu M, Wei B, Li Y, Li N, Tao L, Zhang H, Guo X, Zhao Y. A cross-sectional study in a tertiary care hospital in China: noise or silence in the operating room. BMJ Open. 2017 Sep 18;7(9):e016316. doi: 10.1136/bmjopen-2017-016316.
Sampieri G, Namavarian A, Levin M, Philteos J, Lee JW, Koskinen A, Lin V, Lee J. Noise in Otolaryngology - Head and Neck Surgery operating rooms: a systematic review. J Otolaryngol Head Neck Surg. 2021 Feb 11;50(1):8. doi: 10.1186/s40463-020-00487-6.
Martinez-Millana A, Lizondo A, Gatta R, Vera S, Salcedo VT, Fernandez-Llatas C. Process Mining Dashboard in Operating Rooms: Analysis of Staff Expectations with Analytic Hierarchy Process. Int J Environ Res Public Health. 2019 Jan 11;16(2):199. doi: 10.3390/ijerph16020199.
Grozdanovic D, Janackovic GL, Grozdanovic M, Mitkovic MB, Mitkovic MM. The Selection of Main Surgical Work Factors in Operating Rooms. Inquiry. 2021 Jan-Dec;58:469580211067497. doi: 10.1177/00469580211067497.
Song JJ, Vanneste S, De Ridder D. Dysfunctional noise cancelling of the rostral anterior cingulate cortex in tinnitus patients. PLoS One. 2015 Apr 13;10(4):e0123538. doi: 10.1371/journal.pone.0123538. eCollection 2015.
Zangari S, Mirowsky JE. A simple, cost-effective, and novel method for determining the efficiency of industrial and commercial noise-canceling earmuffs. Noise Health. 2019 May-Jun;21(100):108-115. doi: 10.4103/nah.NAH_52_19.
Ghaleb FA, Kamat MB, Salleh M, Rohani MF, Abd Razak S. Two-stage motion artefact reduction algorithm for electrocardiogram using weighted adaptive noise cancelling and recursive Hampel filter. PLoS One. 2018 Nov 20;13(11):e0207176. doi: 10.1371/journal.pone.0207176. eCollection 2018.
Related Links
Access external resources that provide additional context or updates about the study.
Asco Battery Operated Cannulated Drill Machine, For Industrial
Orthopedic Mallet
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Bvu_Nursing-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.