NCT07665580

Brief Summary

This research is a randomized controlled experimental study conducted to determine the effects of stress ball application and music playback during coronary angiography on patients' pain and anxiety levels and vital signs (systolic/diastolic blood pressure, pulse).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

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

March 3, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

May 19, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

Pain, Anxiety, Nursing Care, Coronary Angiography, Music Therapy, Stress Ball, Vital Signs

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Scale

    Anxiety levels among groups of patients undergoing angiography.

    I evaluated it in 30 minutes.

Secondary Outcomes (1)

  • Visual Analog Scale (VAS)

    I finished it in 30 minutes.

Study Arms (3)

Control Group

NO INTERVENTION

The normal procedure was followed.

stress ball Group

EXPERIMENTAL

Participants receive a stress ball during the procedure/intervention period in addition to routine care.

Behavioral: Stress Ball

Music Group

EXPERIMENTAL

Participants listen to music during the procedure/intervention period in addition to routine care.

Behavioral: Music Therapy

Interventions

Stress BallBEHAVIORAL

Participants are provided with a stress ball to squeeze during the procedure.

stress ball Group
Music TherapyBEHAVIORAL

Participants listen to relaxing music during the procedure.

Music Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa City Hospital

Manisa, Yunusemre, 45010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hüseyin Buğra Çiftçi, Master Students

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this study, participants did not know which group they belonged to. The statistician performing the statistical analysis did not know the groups.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: There are 3 groups: control group, music group, and stress ball group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Students

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 24, 2026

Study Start

March 3, 2025

Primary Completion

October 21, 2025

Study Completion

March 31, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations