Effect of Stress Ball in Angiography

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Behavioral: experimental group

• Registration Number: NCT06131606
• Lead Sponsor: Firat University

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.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-15
• Status Verified: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	experimental group	During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	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 Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI)	two weeks	The scale was developed by Spielberger et al. Its reliability and validity in our country were performed by Öner and Le Compte. The scale consists of two subunits that measure anxiety separately, but in this study, the state-trait anxiety that patients feel indirectly from the stressful situation they are in will be used. A scale of 4-point Likert-type consisting of 20-item short statements measures the state-trait anxiety level of the individual.

Trial Locations

Locations (1)

Firat Universty; 🇹🇷 Elazığ, Turkey