Anterior Cruciate Ligament TearNCT06275828
The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction
A study testing slow beat mesic listening by headphone in people with Anterior Cruciate Ligament Tear, run by Police General Hospital, Thailand at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- slow beat mesic listening by headphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- 15 Dec 2022to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis Anterior cruciate ligament tear from MRI
- Plan to surgery by arthroscopic ACL reconstruction
- must able to listening music from headphone
Who cannot join
- Hearing problem
- History of morphine and pethidine allergy
- History of previous knee surgery
- intraoperative finding multiple ligament injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction.
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
- Patient age : More than 18 years old
- The patient have diagnosis ACL injury by MRI and go on surgery by arthroscopic surgery Exclusion criteria
- 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
- Being tested
- slow beat mesic listening by headphone
- Keywords
- anterior cruciate ligament reconstruction, music therapy, postoperative pain, pain score, anxiety
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow beat mesic listening by headphoneDevice
classic slow beat type from researcher
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Experimental | Not described Receives: Device: slow beat mesic listening by headphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
pain score from 0 to 10 (0=no pain, 10=Worst pain)
Measured: post op 1,3,12,24,48,72 hours before discharge from hospital
Secondary outcomes (2)
analgesic drug use
dose of analgesic drug use (morphine, pethidine)
Measured: post op 1,3,12,24,48,72 hours before discharge from hospital
Amsterdam Preoperative Anxiety and Information Scale
Score from 6(Least anxiety) to 30(maximum anxiety)
Measured: pre-operative and post operative at ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Dec 2022
- Primary completion31 Jul 2023
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Police General Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peerapat Tansakul, Police General Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275828
- Sponsor's protocol ID
- PoliceGeneralHospiral
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction.
- ClinicalTrials.gov ID
- NCT06275828
- Acronym / sponsor ID
- PoliceGeneralHospiral
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- anterior cruciate ligament reconstruction, music therapy, postoperative pain, pain score, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Police General Hospital, ThailandUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patient age : More than 18 years old
- The patient have diagnosis ACL injury by MRI and go on surgery by arthroscopic surgery Exclusion criteria
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Experimental | Device: slow beat mesic listening by headphone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis Anterior cruciate ligament tear from MRI
- Plan to surgery by arthroscopic ACL reconstruction
- must able to listening music from headphone
Key exclusion criteria (4 listed)
- Hearing problem
- History of morphine and pethidine allergy
- History of previous knee surgery
- intraoperative finding multiple ligament injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| slow beat mesic listening by headphoneclassic slow beat type from researcher | Device | intervention |
Primary outcome
visual analog scale
Time frame: post op 1,3,12,24,48,72 hours before discharge from hospital
pain score from 0 to 10 (0=no pain, 10=Worst pain)
2 secondary outcomes
analgesic drug use
Time frame: post op 1,3,12,24,48,72 hours before discharge from hospital
Amsterdam Preoperative Anxiety and Information Scale
Time frame: pre-operative and post operative at ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing slow beat mesic listening by headphone in people with Anterior Cruciate Ligament Tear, run by Police General Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: post op 1,3,12,24,48,72 hours before discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.