NCT07424339

Brief Summary

This randomized controlled study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. Patients scheduled for angiography were randomly assigned to either a music intervention group or a control group receiving routine care. Anxiety levels were assessed using validated anxiety measurement tools, and vital signs including blood pressure, heart rate, and oxygen saturation were recorded at multiple time points before, during, and after the procedure. In the intervention group, selected music was played throughout the angiography procedure, while no music intervention was applied to the control group. This study evaluates the role of music as a non-pharmacological intervention for anxiety management during angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2025

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

June 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 6, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

AnxietyVital SignsMusicCoronary Angiography

Outcome Measures

Primary Outcomes (1)

  • Anxiety levels

    Anxiety level assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A; score range 0-21) and the Distress Thermometer (score range 0-10). Higher scores indicate greater anxiety/distress.

    Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure

Secondary Outcomes (1)

  • Vital Sign Level

    Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure

Study Arms (2)

Music Therapy Group

EXPERIMENTAL

Participants in this group will receive music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure.

Behavioral: Music intervention

Control Group

NO INTERVENTION

Participants in this group will receive standard care without music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure.

Interventions

This intervention differs from other clinical interventions because it involves passive music listening in the procedure room rather than formal therapy, drugs, or devices. Headphones are not used in order to avoid interfering with communication between the patient and healthcare staff. It is a non-therapeutic, behavioral intervention designed to assess its effect on anxiety and vital signs during angiography.

Music Therapy Group

Eligibility Criteria

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

You may qualify if:

  • Patients aged between 18 and 65 years
  • Literate patients
  • Patients who voluntarily agree to participate in the study

You may not qualify if:

  • Clinically unstable patients
  • Patients scheduled for emergency angiography
  • Patients with hearing impairment
  • Patients who have used any analgesic medication prior to the procedure
  • Patients unable to communicate in Turkish
  • Patients using anxiolytic or sedative medications
  • Patients without a psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtısas University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMental Disorders

Study Officials

  • Dilara Yıldızoğlu, MSc

    Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department

    PRINCIPAL INVESTIGATOR
  • Arzu Aydoğan, Assistant Professor

    Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No parties are masked in this study. Both the participants and the investigators are aware of the intervention. The study is conducted as an open-label trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled interventional study designed to evaluate the effect of music therapy during angiography on patients' anxiety levels and vital signs. Participants who meet the inclusion criteria will be randomly assigned to either the intervention group, which will receive music therapy during the procedure, or the control group, which will receive standard care without music. Baseline measurements of anxiety and vital signs will be taken before the procedure, and post-intervention measurements will be recorded immediately after the procedure. The primary outcome is the change in anxiety levels, while secondary outcomes include changes in heart rate, blood pressure, and other vital signs.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 20, 2026

Study Start

June 13, 2025

Primary Completion

November 13, 2025

Study Completion

November 15, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant privacy and confidentiality.

Locations