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

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06275828
• Other study ID #: PoliceGeneralHospiral
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: Police General Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: February 20, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Device:
• slow beat mesic listening by headphone
classic slow beat type from researcher

Locations

Country	Name	City	State
Thailand	Police General Hospital	Bangkok	Pathuwam

Sponsors (1)

Lead Sponsor	Collaborator
Police General Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

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