NCT03816501

Brief Summary

In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

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 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

January 23, 2019

Last Update Submit

September 24, 2019

Conditions

Music on Postoperative Anxiety

Keywords

postoperative anxietyState - Trait Anxiety Inventory

Outcome Measures

Primary Outcomes (2)

  • STAI score

    preoperative and postoperative STAI I and II score questions will be asked.

    24 hours

  • 11-point numerical rating scale (NRS)

    11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

    24 hours

Study Arms (2)

music

OTHER

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

Other: music

no music

OTHER

preoperative music will not be listened

Other: no music

Interventions

musicOTHER

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

music
no musicOTHER

the patients will not be listened

no music

Eligibility Criteria

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

You may qualify if:

  • inguinal hernia surgery
  • speak Turkish language

You may not qualify if:

  • Patients with dementia and psychiatric disorders
  • anxiolytic and psychiatric drug users
  • patients without written consent
  • poor vision,
  • significant hearing loss,
  • active opioid use,
  • unwillingness to participate in the study
  • unwillingness to listening to music

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

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

January 23, 2019

First Posted

January 25, 2019

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

May 15, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)