Clinical trial NCT05714267: Effect of Noise Control During Total Knee Arthroplasty
Official title: The Effect of Noise Control and Music Therapy on Anxiety, Vital Signs and Post-Operative Pain in Total Knee Prosthesis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Music therapy
Active noise control
Pasive noise control
Knee replacement
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: State and trait anxiety scale
timeFrame: Before the surgery
measure: Visual Analog Scale
timeFrame: Change from baseline to 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
state: Fatih
Study officials:
affiliation: Doğuş University
name: Deniz Öztekin, Professor
role: STUDY_DIRECTOR
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