NCT06764407

Brief Summary

In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

January 2, 2025

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spielberg State-Trait Anxiety Inventory (STAI) score

    The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.

    Preoperative 1st hour and Postoperative 4th hour

Secondary Outcomes (5)

  • Numerical Rating Scale (NRS)

    Postoperative 4th, 12th and 24th hours

  • The quality of postoperative functional recovery (QoR-15) score

    Preoperative 1st hour and Postoperative 24th hour

  • Patient satisfaction score

    Postoperative 24th hour

  • MCID of STAI score

    24 hour

  • MCID of QoR-15 score

    24 hour

Study Arms (2)

Patient preferential music

ACTIVE COMPARATOR

The preference of the patients will be listened to preoperatively through the headphones.

Other: Patient preferential music

No Music

PLACEBO COMPARATOR

Patients will not listen to music.

Other: No Music

Interventions

Patients will listen to their preferred music through the headphones before surgery and intraoperative period.

Patient preferential music

Patients will not listen to music.

No Music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergo Total Knee Arthroplasty Under Spinal Anesthesia

You may not qualify if:

  • Poor vision
  • Significant hearing loss
  • Dementia
  • Active opioid use
  • Regular use of anxiolytics or discontinuation of them on the day of surgery
  • Unwillingness to participate in the study
  • Unwillingness to listening to music

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Kavak Akelma F, Altinsoy S, Arslan MT, Ergil J. Effect of favorite music on postoperative anxiety and pain. Anaesthesist. 2020 Mar;69(3):198-204. doi: 10.1007/s00101-020-00731-8. Epub 2020 Feb 11.

    PMID: 32047952BACKGROUND
  • Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.

    PMID: 23740695BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

January 9, 2025

Primary Completion

March 3, 2025

Study Completion

April 1, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations