- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665580
The Effect Of Paın And Anxıety Durıng Coronary Angıography
The Effect Of Stress Ball And Musıc Interventıon Applıed To Patıents Durıng Coronary Angıography On Paın And Anxıety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: This research is a randomized controlled experimental study conducted to determine the effects of stress ball application and music listening during coronary angiography on patients' pain and anxiety levels and vital signs (systolic/diastolic blood pressure, pulse). Materials and Methods: The study sample consisted of 180 individuals who applied for coronary angiography at the cardiology laboratory of a city hospital between March and December 2025, including 60 control group, 60 stress ball group, and 60 music group, totaling 180 individuals. Data were collected using the "Patient Identification Form," "Visual Analog Scale (VAS)," "State-Trait Anxiety Scale (STAI-1)," and "Vital Signs Form." Patients in the intervention groups received the prescribed protocols (standard music playlist or stress ball placement in the dominant hand) throughout the procedure, while the control group received only routine clinical care.
Findings: Patients who used a stress ball and listened to music during coronary angiography had statistically significantly lower mean post-procedure pain and anxiety scores compared to the control group (p<0.05). Although there was a significant difference in anxiety and pain levels between the intervention groups, both methods were determined to be effective compared to standard care. Conclusion: It can be said that stress ball and music therapy methods applied during coronary angiography are effective, reliable, and cost-effective non-pharmacological nursing interventions in reducing patients' pain and anxiety levels and stabilizing hemodynamic parameters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yunusemre
-
Manisa, Yunusemre, Turkey (Türkiye), 45010
- Manisa City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those undergoing coronary angiography for the first time,
- Those undergoing groin angiography,
- Those over 18 years of age,
- Those who are not drug or alcohol dependent,
- Those who do not have hearing impairments,
- Those who have not used any medication that will produce an analgesic effect within 6 hours before the procedure,
- Those who are not prevented from using a stress ball in their left hand,
- Those who are oriented to the place and time,
- Those who do not have a history of serious psychological problems in the past 6 months,
- Those who do not use any medication that suppresses anxiety symptoms,
- Those who agree to participate in the study are included.
Exclusion Criteria:
- Patients with severe heart failure or serious cardiovascular disease,
- Patients who will require sedation or anesthesia during the procedure,
- Patients who dislike music for cultural reasons,
- Patients who require urgent treatment for cardiac dysrhythmias,
- Patients with hearing problems,
- Patients who cannot actively use their hands (such as those with hemiplegia, fractures, fistulas, etc.) are not included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The normal procedure was followed.
|
|
|
Experimental: stress ball Group
Participants receive a stress ball during the procedure/intervention period in addition to routine care.
|
Participants are provided with a stress ball to squeeze during the procedure.
|
|
Experimental: Music Group
Participants listen to music during the procedure/intervention period in addition to routine care.
|
Participants listen to relaxing music during the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Scale
Time Frame: I evaluated it in 30 minutes.
|
Anxiety levels among groups of patients undergoing angiography.
|
I evaluated it in 30 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: I finished it in 30 minutes.
|
Pain assessment between groups during angiography for the patient.
|
I finished it in 30 minutes.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hüseyin Buğra Çiftçi, Master Students, Manisa Celal Bayar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Mental Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Anxiety Disorders
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- MCBÜ-HEM-HC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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