The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During PCI

NCT05514574 | Completed DMC

• 1 other identifier: KYildiz
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI).

Conditions

Percutaneous Coronary Intervention; Anxiety; Hemodynamics

Keywords

percutaneous coronary intervention; anxiety; hemodynamics; music; stress ball

Outcome Measures

Primary Outcomes (1)

• State Anxiety Score

  Change in State Anxiety Score after intervention.

  Each participant's State Anxiety score will be measured before and after admission to (twice-daily) the percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.

Secondary Outcomes (6)

• Systolic Blood Pressure Value (mmHg)

  Systolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form

• Diastolic Blood Pressure Value (mmHg)

  Diastolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.

• Mean Arterial Pressure Value (mmHg)

  Mean Arterial Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.

• Heart Rate/Minute Value

  Heart Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.

• Respiratory Rate/Minute Value

  Respiratory Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.

Study Arms (3)

Music

EXPERIMENTAL

Patients (listening to music group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will listen to music during the procedure.

Other: Music

Stress ball

EXPERIMENTAL

Patients (stress ball group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will stress ball will be applied during the procedure.

Other: Stress ball

Control

NO INTERVENTION

Patients (control group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; No intervention will be performed except for routine treatment and care interventions.

Interventions

Music OTHER

"hussoni duseni " music

Music

Stress ball OTHER

Stress ball squeeze

Stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older,
• Literate,
• Able to communicate verbally,
• Turkish speaking,
• No hearing or vision loss,
• No sensory or motor deficits in the hand or arm,
• Percutaneous coronary intervention will be applied,
• intervention from the femoral artery,
• Voluntarily participated in the research,
• Patients signing the informed consent form will be included.

You may not qualify if:

• Under the age of 18,
• Not signing the informed consent form,
• Illiterate,
• Unable to speak Turkish,
• Unable to communicate verbally
• Those who have a neurological or psychiatric disease that prevents communication,
• Hearing and sight impaired,
• Those who have had a mastectomy
• Those with arterio-venous fistula
• Percutaneous coronary intervention has been performed in the last 2 years,
• Restricted special groups (pregnant women, criminal convicts, etc.),
• Emergency cases where communication cannot be established,
• Those with equipment problems such as monitors and cuffs,
• Those who will be given sedatives during the procedure,
• Those who will be taking cardiovascular system medications other than routine practices during the procedure,

Sponsors & Collaborators

• Keriman Yildiz: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• SERPİL YÜKSEL, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• AHMET YILMAZ, PhD

  Karamanoğlu Mehmetbey University

  STUDY DIRECTOR

• KERİMAN YILDIZ, MSc

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients and their relatives, clinical staff, will be blinded to the group assignment. Evaluation of the data will be done by a blinded technique by a biostatistician not involved in the study and blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Model Details: Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 24, 2022
• Study Start: August 2, 2022
• Primary Completion: February 22, 2023
• Study Completion: October 27, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After December 1, 2024
• Access Criteria: Anyone who wishes to access the data. Study Protocol.

Locations

TU (1)