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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.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275828
Enrollment
46
Registered
2024-02-23
Start date
2022-12-15
Completion date
2024-02-20
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Tear

Keywords

anterior cruciate ligament reconstruction, music therapy, postoperative pain, pain score, anxiety

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.

Interventions

DEVICEslow beat mesic listening by headphone

classic slow beat type from researcher

Sponsors

Police General Hospital, Thailand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
visual analog scalepost op 1,3,12,24,48,72 hours before discharge from hospitalpain score from 0 to 10 (0=no pain, 10=Worst pain)

Secondary

MeasureTime frameDescription
analgesic drug usepost op 1,3,12,24,48,72 hours before discharge from hospitaldose of analgesic drug use (morphine, pethidine)
Amsterdam Preoperative Anxiety and Information Scalepre-operative and post operative at wardScore from 6(Least anxiety) to 30(maximum anxiety)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026