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Clinical Trials/NCT06131606
NCT06131606
Completed
Not Applicable

Effect of Stress Ball in Angiography: A Randomized Controlled Trial

Firat University1 site in 1 country120 target enrollmentJanuary 10, 2023
ConditionsPain, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Firat University
Enrollment
120
Locations
1
Primary Endpoint
Numerical Rating Scale (NRS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures.

Detailed Description

The purpose of this research was to investigate the effect of stress ball application, which is a non-pharmacologic method, on the pain and anxiety levels of patients during the angiography procedure. The present randomized controlled trial was conducted on all adult patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of 120 randomized patients who underwent stress ball application and received routine care. Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory (STAI) were employed for data collection. The mean NRS posttest score of the experimental group patients increased significantly less than the control group (p\<0.001), while the mean STAI posttest score decreased significantly (p= 0.019). A positive significant correlation was determined between the mean NRS and STAI post-test scores of the patients in the experimental group (p\<0.05). It was found that the level of state-trait anxiety decreased as the pain decreased. The stress ball applied during angiography decreased the anxiety and pain levels of the patients. Stress ball application may be recommended as a complementary method to support pharmacologic treatment.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
July 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Firat University
Responsible Party
Principal Investigator
Principal Investigator

Dilek Güneş

Assistant Professor

Firat University

Eligibility Criteria

Inclusion Criteria

  • no communication problems,
  • being older than 18 years of age,
  • having good mental health,
  • undergoing wrist angiography (Radial Angiography),
  • being willing to take part in the study.

Exclusion Criteria

  • Any complication during angiography.

Outcomes

Primary Outcomes

Numerical Rating Scale (NRS)

Time Frame: two weeks

This scale, which assesses the degree of pain, aims to make the patient express their pain in numbers. It starts with no pain (0) and goes up to unbearable pain (10 or 100). The high level of pain reporting is known as a disadvantage. Miró et al. found that the validity of the NRS for pain assessment was at an acceptable level (Miró et al., 2009). Hjermstad et al. compared the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), and Verbal Descriptor Scale (VDS) for the assessment of pain intensity in adults and found that the NRS was more understandable and easier to use than the VAS and VDS

Secondary Outcomes

  • State-Trait Anxiety Inventory (STAI)(two weeks)

Study Sites (1)

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