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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Tear
• Intervention / Treatment: Device: slow beat mesic listening by headphone

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Pathuwam
    • Bangkok, Pathuwam, Thailand, 10330
      • Police General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: intervention	Device: slow beat mesic listening by headphone; classic slow beat type from researcher

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	pain score from 0 to 10 (0=no pain, 10=Worst pain)	post op 1,3,12,24,48,72 hours before discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic drug use	dose of analgesic drug use (morphine, pethidine)	post op 1,3,12,24,48,72 hours before discharge from hospital
Amsterdam Preoperative Anxiety and Information Scale	Score from 6(Least anxiety) to 30(maximum anxiety)	pre-operative and post operative at ward

Collaborators and Investigators

• Sponsor: Police General Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): February 20, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; music therapy; postoperative pain; pain score; anterior cruciate ligament reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: PoliceGeneralHospiral

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