NCT04276506

Brief Summary

Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Its important to determine of the level of anxiety so experienced nurses carried out various interventions to reduce anxiety. This study aims to determine the effect of listening music and getting information on the level of anxiety and vital signs of the patients who are planned to undergo coronary angiography. For this purpose, calming music which is suitable for the heart rhythm and booklets which is prepared with various visuals will be used. In the study, apart from a control group that routine clinical procedures will be applied, there will be two more groups which are called as music and information groups. Patients' participation in these groups will be distributed randomly by computer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

September 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 27, 2020

Last Update Submit

September 24, 2020

Conditions

Keywords

AnxietyCoronary AngiographyNursingMusicVisual InformationPhysiological parameters

Outcome Measures

Primary Outcomes (1)

  • State anxiety level

    Use of the State-Trait Anxiety Inventory (STAI) to assess the level of anxiety

    1 day

Secondary Outcomes (3)

  • heart rate

    1 day

  • respiratory rate

    1 day

  • blood pressure

    1 day

Study Arms (3)

information booklet group

EXPERIMENTAL

information session before the coronary angiography

Other: information group

music group

EXPERIMENTAL

music session before the coronary angiography

Other: music group

control group

NO INTERVENTION

No information or music session before the coronary angiography

Interventions

to reduce anxiety, some selected music pieces will have patients listened by headset.

music group

A visual information booklet which is prepared by the researchers will be used

information booklet group

Eligibility Criteria

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

You may qualify if:

  • adult
  • patients who undergoing coronary angiography first time
  • able to speak and understand turkish
  • people informed clearly by the investigator

You may not qualify if:

  • having any hearing and visual problems
  • being on psychiatric medications
  • emergency cases
  • patient under legally protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EMU Health Science Faculty

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Handan Sezgin, Assist Prof.

    Eastern Mediterranean University Health Science Faculty

    STUDY DIRECTOR
  • Nurdan Yıldız, Msc

    Eastern Mediterranean University Health Science Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 19, 2020

Study Start

November 10, 2019

Primary Completion

January 10, 2020

Study Completion

March 10, 2020

Last Updated

September 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations