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Active, not recruitingNCT06275828Updated Feb 23, 2024

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

An interventional study of slow beat mesic listening by headphone in Anterior Cruciate Ligament Tear, sponsored by Police General Hospital, Thailand. Active, not recruiting at 1 site in Thailand. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Police General Hospital, Thailand · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Dec 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Anterior Cruciate Ligament Tear

Keywords

  • anterior cruciate ligament reconstruction
  • music therapy
  • postoperative pain
  • pain score
  • anxiety
03

In context

Anterior Cruciate Ligament Injuries

625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.

This study's enrollment of 46 is below the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Police General Hospital, Thailand is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Hearing problem
  • History of morphine and pethidine allergy
  • History of previous knee surgery
  • intraoperative finding multiple ligament injury
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • No intervention
    control
  • Experimental
    intervention

    Device: slow beat mesic listening by headphone

Interventions

  • Deviceslow beat mesic listening by headphone

    classic slow beat type from researcher

06

What researchers measure

Primary outcomes

  1. visual analog scale

    pain score from 0 to 10 (0=no pain, 10=Worst pain)

    Time frame: post op 1,3,12,24,48,72 hours before discharge from hospital

Secondary outcomes

  1. analgesic drug use

    dose of analgesic drug use (morphine, pethidine)

    Time frame: post op 1,3,12,24,48,72 hours before discharge from hospital

  2. Amsterdam Preoperative Anxiety and Information Scale

    Score from 6(Least anxiety) to 30(maximum anxiety)

    Time frame: pre-operative and post operative at ward

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Jul 2023, 7 months.

Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's 7 months is below that.

Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2024
First posted
Feb 23, 2024
StartActual
Dec 15, 2022
Primary completionActual
Jul 31, 2023
CompletionEst.
Feb 20, 2024
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06275828
Lead sponsor
Police General Hospital, Thailand
Responsible party
Peerapat Tansakul (Director, Police General Hospital, Thailand) — Principal investigator
First posted
Feb 23, 2024
Start date
Dec 15, 2022
Primary completion
Jul 31, 2023
Completion
Feb 20, 2024 (estimated)
Last update
Feb 23, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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