NCT04277559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

May 19, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

February 18, 2020

Last Update Submit

May 18, 2023

Conditions

Keywords

Patient preferential musicPostoperative anxietyClassical music

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.

    4 hours

Secondary Outcomes (3)

  • Numerical Rating Scale (NRS)

    24 hours

  • The quality of postoperative functional recovery (QoR-40) score

    24 hours

  • Patient satisfaction score

    24 hours

Study Arms (3)

Patient preferential music

ACTIVE COMPARATOR

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

Other: Patient preferential music

Classical music

ACTIVE COMPARATOR

Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones.

Other: Classical music

No music

PLACEBO COMPARATOR

the patients will not listen.

Other: No music

Interventions

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

Patient preferential music

Patients will listen to classical music through headphones before surgery.

Classical music

Patients will not listen to music.

No music

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergo inguinal hernia surgery under general anesthesia,
  • Being the ability to speak, read and write the Turkish language

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)

Dışkapı Yıldırım Beyazıt Training and Research Hospital

Ankara, Gölbaşı, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Akelma FK, Altinsoy S, Nalbant B, Ozkan D, Ergil J. Comparison of classical and patient-preferred music on anxiety and recovery after inguinal hernia repair: a prospective randomized controlled study. Perioper Med (Lond). 2024 Aug 14;13(1):89. doi: 10.1186/s13741-024-00434-3.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology and reanimation specialist doctor

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

November 1, 2021

Primary Completion

July 1, 2022

Study Completion

October 1, 2022

Last Updated

May 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations