CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Active noise cancelling +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05714267
NCT05714267N/ACompleted

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

Bezmialem Vakif University·interventional·Posted Feb 6, 2023·Updated Aug 9, 2024

In Brief

A clinical study evaluating Active noise cancelling, Passive noice cancelling, and 1 other intervention for Knee Osteoarthritis. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 6, 2023
Enrollment StartNov 1, 2021
Primary CompletionAug 1, 2023
Study CompletionAug 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.4 years ago

Interventions

Active noise cancellingdevice

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 cancellingdevice

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 therapydevice

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.