NCT04651075

Brief Summary

The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable coronary-artery-disease

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

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

June 26, 2020

Last Update Submit

April 20, 2022

Conditions

Keywords

Coronary AngiographyTeachingMusic theraphyAnxietyNursing care

Outcome Measures

Primary Outcomes (1)

  • means of subjective anxiety scores

    Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety.

    up to 45 minutes

Secondary Outcomes (1)

  • means of subjective pain scores

    up to 45 minutes

Other Outcomes (3)

  • means of blood pressure (mmHg)

    up to 45 minutes

  • means of heart rate (/min)

    up to 45 minutes

  • means of respiratory rate (/min)

    up to 45 minutes

Study Arms (3)

music theraphy

EXPERIMENTAL

One of the 4 music genres (Turkish Folk, Classical, Turkish Art and Sufi Music), which was determined by the researcher by scanning the literature 30 minutes before the CAG procedure, and the expert opinion was taken to the participants in this group was played with a 5-minute headset. The musical genres were arranged in instrumental, nonverbal, 70 decibels in terms of rhythm and duration and played according to the individual's choice.

Other: music listening

information education

EXPERIMENTAL

Participants in this group were trained to inform them about CAG in visual, audio and written form. Information training was provided by the researcher 30 minutes before the CAG procedure after the outpatient clinic controls of the patient. Information education prepared by the researcher by scanning the literature and getting expert opinion; It includes 7 minutes of video explanation about the CAG process, discussion after video watching, question and answer, and the delivery of a training book prepared in written form.

Other: individual training

nursing care

NO INTERVENTION

Individuals in this group received routine nursing care and no intervention was made by the researcher. In routine nursing care for individuals who will receive CAG procedure in the clinic; Preparation for the CAG procedure, which involves opening the vascular access and dressing the surgical gown, is included in the pre-and post-procedure routine once and more frequently when there are deviations from normal, and if the patient asks questions about the procedure, measurement of blood pressure, heart rate and oxygen saturation.

Interventions

The music selected by the participants was played to the music listening group.

music theraphy

Individual training group was trained on coronary angiography.

information education

Eligibility Criteria

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

You may qualify if:

  • Applying femoral CAG electively,
  • The first time CAG will be held,
  • Performing the CAG procedure for diagnostic purposes,
  • Not trained on the CAG process,
  • Volunteering to participate in the study,
  • No problem in verbal communication,
  • No hearing loss,
  • Being able to read and write,
  • Has not been diagnosed with psychiatric illness,
  • Being conscious,
  • Being 18 or older.

You may not qualify if:

  • Radial application of CAG,
  • Previously performing coronary angiography,
  • Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.),
  • Having received training on the KAG process,
  • Does not want to participate in the study
  • Problems in verbal communication,
  • Hearing loss,
  • Psychiatric illness is found.
  • Consciousness is closed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant İzzet Baysal University

Bolu, Merkez, 14100_, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participant did not know which group he was in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 3 groups as intervention and control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

December 3, 2020

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations