The Effect of Music Played During the Angiography Procedure on Patients' Anxiety Levels and Vital Signs
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Dilara Yıldızoğlu

 
 
 
Official Study Title: 
The Effect of Music Played During the Angiography Procedure on Patients’ 
Anxiety Levels and Vital Signs 
 
ClinicalTrials.gov Identifier (NCT Number): 
NCT Pending 
 
Document Type: 
Study Protocol and Statistical Analysis Plan 
 
Document Date: 
21 May 2025 
 
Sponsor / Responsible Party: 
Yuksek Ihtisas University 
Faculty of Health Sciences 
Department of Nursing 
 
 

The Effect of Music Played During the Angiography Procedure on Patients’ Anxiety 
Levels and Vital Signs 
Research Summary 
This study was conducted to determine the effect of music played during the angiography 
procedure on patients’ anxiety levels and vital signs. The study was designed as a quantitative, 
experimental, pretest–posttest randomized controlled trial. Stratified randomization was 
applied, and patients were assigned to groups according to risk factors including physician, 
gender, and age. The randomization process was carried out in accordance with the principle of 
probabilistic assignment. Participants were allocated to the intervention and control groups 
using a computer-assisted simple randomization method, and the online randomization tool 
www.randomizer.org was used. 
The study was carried out between June 2025 and November 2025 with patients who applied 
to the cardiology outpatient clinic of Private 100th Year Hospital and were scheduled to 
undergo angiography. The study was conducted in the Angiography Unit of the same hospital, 
and the necessary institutional permissions were obtained prior to data collection. 
Aim 
The aim of this study was to examine the effect of listening to music during the angiography 
procedure on patients’ anxiety levels and vital signs. 
Research Hypotheses 
H01: Music had no effect on reducing anxiety levels in patients undergoing angiography. 
H11: Music had an effect on reducing anxiety levels in patients undergoing angiography. 
H02: Music had no effect on vital signs in patients undergoing angiography. 
H12: Music had an effect on vital signs in patients undergoing angiography. 
Method 
This study was conducted as a quantitative, experimental, pretest–posttest randomized 
controlled trial. 
Study Setting and Permission Status 
The study was conducted in the Angiography Unit of Private 100th Year Hospital. The 
necessary institutional permission for the study was obtained prior to data collection. 

 
Study Sample 
The study sample consisted of patients who applied to the cardiology outpatient clinic of Private 
100th Year Hospital, were scheduled for angiography, and met the study inclusion criteria. Prior 
to the study, a power analysis was performed using G*Power version 3.1.9.7 to determine the 
required sample size. Based on an alpha level of 0.05, an effect size of 1.05, and a statistical 
power of 0.95, the analysis indicated that a minimum of 25 participants in the intervention group 
and 25 participants in the control group, for a total of 50 participants, was required. The sample 
size calculation was supported by Prof. Dr. Bülent Çelik from the Faculty of Science, 
Department of Statistics, Gazi University. 
Data Collection Procedure 
After preoperative ECG recording, patients in both the intervention and control groups who met 
the inclusion criteria completed the Personal Information Form, the Hospital Anxiety Scale, 
and the Distress Thermometer as pretest measures. Vital signs were measured and recorded 
using the Vital Signs Monitoring Form. For patients in the intervention group whose 
preparations were completed and who were admitted to the angiography unit, selected music 
was played via a wireless Bluetooth speaker, and the music intervention continued throughout 
the angiography procedure. Patients were informed that they could control the volume of the 
music at any time, including increasing or decreasing the volume, stopping the music, or 
restarting it. To avoid interrupting communication with healthcare personnel, headphones were 
not used. Patients in the control group underwent the angiography procedure according to the 
hospital’s routine clinical workflow without any additional intervention. 
During the intraoperative period, anxiety levels of patients in both groups were assessed using 
the Distress Thermometer, and vital signs were recorded. Fifteen minutes after the completion 
of the procedure, posttest assessments were conducted by re-administering the Hospital Anxiety 
Scale and the Distress Thermometer, and vital signs were re-measured and recorded using the 
Vital Signs Monitoring Form. 
Statistical Analysis 
Data analysis and table preparation were performed using SPSS version 28. Quantitative 
variables were presented as mean ± standard deviation or median and interquartile range, while 
qualitative variables were presented as frequency and percentage. Student’s t-test and one-way 
analysis of variance were used when parametric test assumptions were met, whereas the Mann–

Whitney U test and the Kruskal–Wallis H test were applied when parametric assumptions were 
not met. To compare repeated measurements obtained from the intervention and control groups 
at pre-procedure, intra-procedure, and post-procedure time points, a two-way repeated 
measures analysis of variance was used. Pearson or Spearman correlation analyses were 
conducted to examine relationships between variables, and a p-value of less than 0.05 was 
considered statistically significant. 
Inclusion Criteria 
Patients aged 18–65 years, literate patients, and patients who voluntarily agreed to participate 
in the study were included. 
Exclusion Criteria 
Clinically unstable patients, patients scheduled for emergency angiography, patients with 
hearing impairment, patients who had used analgesic, anxiolytic, or sedative medications prior 
to the procedure, patients unable to communicate in Turkish, and patients with a psychiatric 
diagnosis were excluded from the study. 
Ethical Considerations 
Ethical principles were strictly followed throughout the study. Institutional permission was 
obtained, and informed consent was secured from all participants prior to data collection. 
Results and Conclusions 
As a result of the study, anxiety levels of patients in the intervention group were lower than 
those in the control group, and vital signs showed more stable and favorable changes in the 
intervention group. The music intervention was found to be an effective, feasible, and low-cost 
nursing intervention for reducing anxiety levels and maintaining vital signs within normal 
limits.