Effect of Noise Control During Total Knee Arthroplasty

NCT05714267 | Completed DMC

• 1 other identifier: Bvu_Nursing-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Music has emerged as a well-received medical intervention. Patients may be uncomfortable during total joint replacement, which can result in high sedation requirements. These requirements put patients at risk of surgical stress. This study compares the effect of passive noise-cancellation versus active noise cancellation with music on pain, vital signs and anxiety during elective total knee replacement.

Conditions

Knee Osteoarthritis

Keywords

Music therapy; Active noise control; Pasive noise control; Knee replacement

Outcome Measures

Primary Outcomes (2)

• State and trait anxiety scale

  The application period of the scale, which can be applied to all individuals over the age of 14, is ten minutes on average. With the State Anxiety Scale, the individual can evaluate his feelings in a certain place and time according to 20 statements. By using the trait anxiety scale, the feelings of the individual can be evaluated according to these 20 expressions, regardless of the circumstances. The total weighted score for the reverse statements is subtracted from the total weight score for direct statements, and a constant value is added to this number. This value is 50 for the state anxiety scale and 35 for the trait anxiety scale. Both scales are scored between 20-80. A high score indicates high anxiety.

  Before the surgery

• Visual Analog Scale

  Visual Analogue Scale (VAS) was used to evaluate the assumed pain differences between groups. In order to measure the severity of pain with VAS, a 10 cm long ruler was used, in the range of 0-10 points, with "No pain" on one end and "Unbearable pain" on the other end. The patient was told that he was free to mark any part of the ruler, including 0-10. Then, the patient was asked to mark a point showing the severity of the pain on the created ruler. Numerical data were obtained by measuring in centimeters between the zero point of the ruler and the point marked by the patient. The numerical value corresponding to the point marked by the patient on the VAS was recorded in the data collection form. patient's pain; 1. Before surgery, 2. Immediately after the operation, 3. 8 hours after surgery 4. It was evaluated 4 times, 24 hours after the surgery.

  Change from baseline to 1 months

Study Arms (4)

Active noise cancelling

EXPERIMENTAL

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.

Device: Active noise cancelling

Passive noise cancelling

EXPERIMENTAL

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.

Device: Passive noice cancelling

Active noise cancelling with music therapy

EXPERIMENTAL

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.

Device: Active noise cancelling with music therapy

Control group

NO INTERVENTION

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.

Interventions

Active noise cancelling DEVICE

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.

Active noise cancelling

Passive noice cancelling DEVICE

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.

Passive noise cancelling

Active noise cancelling with music therapy DEVICE

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.

Active noise cancelling with music therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 18-80
• 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.

You may not qualify if:

• Having a total knee replacement surgery due to an acquired physical trauma to the knee joint,
• Presence of diagnosed cancer in the patient.
• Being diagnosed with any psychiatric illness,
• Having previously undergone arthroplasty surgery (Revision arthroplasty).

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 24183105 BACKGROUND

• 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.

  PMID: 32181048 BACKGROUND

• 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.

  PMID: 32420262 BACKGROUND

• 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.

  PMID: 35031042 BACKGROUND

• 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.

  PMID: 28928180 BACKGROUND

• 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.

  PMID: 33573705 BACKGROUND

• 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.

  PMID: 30642000 BACKGROUND

• 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.

  PMID: 34908506 BACKGROUND

• 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.

  PMID: 25875099 BACKGROUND

• 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.

  PMID: 32655064 BACKGROUND

• 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.

  PMID: 30457996 BACKGROUND

Related Links

• Asco Battery Operated Cannulated Drill Machine, For Industrial
• Orthopedic Mallet

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deniz Öztekin, Professor

  Doğuş University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: February 6, 2023
• Study Start: November 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 4, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)