NCT05307315

Brief Summary

Many patients before the operation feel a high level of anxiety. This felt anxiety can develop due to many reasons such as anesthesia, not being able to wake up from the surgery and being disabled, and fear of feeling pain after the surgery. Music applications, which are among non-pharmacological techniques, are frequently used in the management of pain and anxiety.In this study, the effect of listening to music in the preoperative period on the anxiety of urology patients will be investigated

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 Sep 2021

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

Study Start

First participant enrolled

September 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
Last Updated

December 2, 2022

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 19, 2021

Last Update Submit

November 30, 2022

Conditions

Keywords

preoperative anxietysurgery anxietyanxiety

Outcome Measures

Primary Outcomes (4)

  • Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory

    The preoperative anxiety levels of the experimental group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.

    within 5 hours before surgery

  • Measuring the preoperative anxiety level of the control group with the State-Trait Anxiety Inventory

    The preoperative anxiety levels of the control group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate high levels of anxiety.

    within 5 hours before surgery

  • Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory after listening to music for 30 minutes

    After listening to music for 30 minutes in the experimental group, their preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.

    15 minutes after listening to music

  • Measuring the preoperative anxiety level of the control group without listening to music with the State-Trait Anxiety Inventory

    Preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory, 45 minutes after the first scales are applied, without listening to music in the control group. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.

    45 minutes after the first scales are applied

Secondary Outcomes (4)

  • Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale

    within 5 hours before surgery

  • Measuring the preoperative anxiety level of the control group with the Surgery-Specific Anxiety Scale

    within 5 hours before surgery

  • Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale after listening to music for 30 minutesmusic

    15 minutes after listening to music

  • Measuring the preoperative anxiety level of the control group without listening to music with the Surgery-Specific Anxiety Scale

    45 minutes after the first scales are applied

Study Arms (2)

music

EXPERIMENTAL

The state/trait anxiety inventory and surgery-specific anxiety inventory will be administered to the experimental group before the surgery. Then they will listen to Turkish Classical Music for 30 minutes. The scales will be applied again 15 minutes after the music ends.

Other: listening to music

control

NO INTERVENTION

The state/trait anxiety inventory and surgery-specific anxiety scale will be administered to the control group before surgery. The same scales will be applied again 45 minutes after the scales are applied.

Interventions

The experimental group will listen to Turkish instrumental music with headphones for 30 minutes.

Also known as: music
music

Eligibility Criteria

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

You may qualify if:

  • To be literate
  • Being undergoing urological surgery for the first time
  • Be over 18 years old
  • Having agreed to participate in the study

You may not qualify if:

  • To be hard of hearing
  • Inability to communicate verbally
  • Having a disease that prevents data collection
  • Having difficulty wearing headphones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neslihan Aker

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sibel Arguvanlı Çoban

    Bülent Ecevit Üniversity

    STUDY DIRECTOR
  • Neslihan Aker

    Bülent Ecevit Üniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

April 1, 2022

Study Start

September 10, 2021

Primary Completion

January 14, 2022

Study Completion

February 1, 2022

Last Updated

December 2, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared

Locations