Effect of Noise Control During Total Knee Arthroplasty

April 12, 2023 updated by: Bezmialem Vakif University

The Effect of Noise Control and Music Therapy on Anxiety, Vital Signs and Post-Operative Pain in Total Knee Prosthesis Surgery

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Unwanted sound that mixes with the sounds being listened to is defined as noise, and the sound community formed by the combination of many noise sources is defined as noise pollution. Environmental noise has many negative effects on human health, such as increasing stress and anxiety, causing the development of cerebral and cardiovascular diseases, and creating a risk of hearing loss.

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Experimental: 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.
Device: 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.
Experimental: 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.
Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State and trait anxiety scale
Time Frame: Before the surgery
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
Time Frame: Change from baseline to 1 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 4, 2023

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bvu_Nursing-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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