NCT06755268

Brief Summary

This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
Last Updated

January 1, 2025

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

September 24, 2024

Last Update Submit

December 23, 2024

Conditions

Keywords

AnxietyComfortCoronary angiographyHemodynamic parametersNursing

Outcome Measures

Primary Outcomes (1)

  • General Comfort Scale

    Scores from the scale range from 48 to 192, and the higher the score, the higher the comfort level.

    before the angiography procedure and after the angiography procedure (average of 15 minutes)

Secondary Outcomes (1)

  • State Anxiety Scale

    before the angiography procedure and after the angiography procedure (average of 15 minutes)

Other Outcomes (1)

  • Hemodynamic Parameters Record Form

    before the angiography procedure and after the angiography procedure (average of 15 minutes)

Study Arms (2)

Application Group

EXPERIMENTAL

After explaining the purpose of the study and the way it was applied to patients in the music group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. The intervention group listened to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.Music was played to the intervention group via a loudspeaker placed in the coronary angiography laboratory.The intervention group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.

Other: listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music

Control Group

NO INTERVENTION

After explaining the purpose of the study and the way it was applied to patients in the control group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. No application was be made to the control group. The control group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.

Interventions

Listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.

Application Group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older
  • Being at least literate
  • Having no mental and cognitive competence
  • Understanding and speaking Turkish
  • Having a planned coronary angiography
  • Performing for diagnostic purposes

You may not qualify if:

  • Having visual and hearing impairment
  • Having a psychiatric diagnosis
  • Using psychiatric medication (tranquilizers, etc.)
  • Using anxiety medication in the last 6 months
  • Having had coronary angiography before
  • The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)
  • An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)
  • coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure
  • Data collection forms were not filled out by the participant after coronary angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

WindWalking

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Air MovementsClimatic ProcessesEcological and Environmental PhenomenaBiological PhenomenaWeatherAtmosphereEnvironmentMeteorological ConceptsRenewable EnergyEnergy-Generating ResourcesEnvironment and Public HealthAirLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2024

First Posted

January 1, 2025

Study Start

February 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 1, 2025

Record last verified: 2024-07

Locations