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Clinical Trials/NCT06275828
NCT06275828
Active, Not Recruiting
N/A

The Effect of Perioperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction.

Police General Hospital, Thailand1 site in 1 country46 target enrollmentDecember 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Tear
Sponsor
Police General Hospital, Thailand
Enrollment
46
Locations
1
Primary Endpoint
visual analog scale
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score

Detailed Description

Objectives Primary Objective : To study and compare pain symptoms between the group of patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, using pain relievers along with listening to music perioperatively and postoperatively. Secondary Objective : To study and compare the levels of anxiety and changes in the circulatory system among patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, from listening to music perioperatively and postoperatively. Research Questions Does listening to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery help reduce postoperative pain? Hypothesis The group of patients who listened to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery will experience reduced postoperative pain compared to the group that did not listen to music. Methodology Randomized Controlled Trial (RCT) Sample Size Calculation The calculation of the sample size for testing two independent means, using the method referenced from the study by Xavier C. Simcock and colleagues on "Intraoperative Music Reduces Perceived Pain After Total Knee Arthroplasty total 38 and add 20% for dropout rate Inclusion criteria 1. Patient age : More than 18 years old 2. The patient have diagnosis ACL injury by MRI and go on surgery by arthroscopic surgery Exclusion criteria 1. History of knee surgery before this visit 2. ACL injury with multiple ligament injury 3. Hearing loss 4. Denial to surgery or include to study Study Design \& Method This study was a randomized control trial of patient knowns ACL injury and undergoing arthroscopic ACL reconstruction surgery between 2022 to 2023. A total 46 patients were included 23 patients in intervention and 23patients in control group. All patients were evaluated using VAS and anxiety scale preoperative and postoperative and intravenous analgesic drug use at 1,3,12,24,48,72 hours after surgery.

Registry
clinicaltrials.gov
Start Date
December 15, 2022
End Date
February 20, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Police General Hospital, Thailand
Responsible Party
Principal Investigator
Principal Investigator

Peerapat Tansakul

Director

Police General Hospital, Thailand

Eligibility Criteria

Inclusion Criteria

  • Diagnosis Anterior cruciate ligament tear from MRI
  • Plan to surgery by arthroscopic ACL reconstruction
  • must able to listening music from headphone

Exclusion Criteria

  • Hearing problem
  • History of morphine and pethidine allergy
  • History of previous knee surgery
  • intraoperative finding multiple ligament injury

Outcomes

Primary Outcomes

visual analog scale

Time Frame: post op 1,3,12,24,48,72 hours before discharge from hospital

pain score from 0 to 10 (0=no pain, 10=Worst pain)

Secondary Outcomes

  • Amsterdam Preoperative Anxiety and Information Scale(pre-operative and post operative at ward)
  • analgesic drug use(post op 1,3,12,24,48,72 hours before discharge from hospital)

Study Sites (1)

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