Clinical trial NCT06275828: The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction
Official title: The Effect of Perioperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: anterior cruciate ligament reconstruction
music therapy
postoperative pain
pain score
anxiety
Lead sponsor: Police General Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: visual analog scale
timeFrame: post op 1,3,12,24,48,72 hours before discharge from hospital
Secondary outcomes:
measure: analgesic drug use
timeFrame: post op 1,3,12,24,48,72 hours before discharge from hospital
measure: Amsterdam Preoperative Anxiety and Information Scale
timeFrame: pre-operative and post operative at ward
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Police General Hospital
state: Pathuwam
Study officials:
References: