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

NCT ID: NCT06275828

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-02-20

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.

Conditions

Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

Group Type: EXPERIMENTAL

slow beat mesic listening by headphone

Intervention Type: DEVICE

classic slow beat type from researcher

Interventions

slow beat mesic listening by headphone

classic slow beat type from researcher

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Police General Hospital, Thailand

OTHER

Sponsor Role: lead

Responsible Party

Peerapat Tansakul

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Police General Hospital

Bangkok, Pathuwam, Thailand

Countries

Thailand

Other Identifiers

PoliceGeneralHospiral

Identifier Type: -

Identifier Source: org_study_id