NCT06275828

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 27, 2024

Last Update Submit

February 16, 2024

Conditions

Anterior Cruciate Ligament Tear

Keywords

anterior cruciate ligament reconstructionmusic therapypostoperative painpain scoreanxiety

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

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

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

Secondary Outcomes (2)

  • analgesic drug use

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

  • Amsterdam Preoperative Anxiety and Information Scale

    pre-operative and post operative at ward

Study Arms (2)

control

NO INTERVENTION

intervention

EXPERIMENTAL
Device: slow beat mesic listening by headphone

Interventions

slow beat mesic listening by headphoneDEVICE

classic slow beat type from researcher

intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis Anterior cruciate ligament tear from MRI
  • Plan to surgery by arthroscopic ACL reconstruction
  • must able to listening music from headphone

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Police General Hospital

Bangkok, Pathuwam, 10330, Thailand

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesPain, PostoperativeAnxiety Disorders

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 27, 2024

First Posted

February 23, 2024

Study Start

December 15, 2022

Primary Completion

July 31, 2023

Study Completion

February 20, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)