Effect of Stress Ball in Angiography

NCT06131606 | Completed

• 1 other identifier: FU-SN-DG-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

Pain; Angiography; Anxiety; Nursing; Stress ball

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  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

  two weeks

Secondary Outcomes (1)

• State-Trait Anxiety Inventory (STAI)

  two weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Behavioral: experimental group

control group

NO INTERVENTION

No intervention other than the clinic protocol was applied to this group.

Interventions

experimental group BEHAVIORAL

Patients in the experimental group were told how to use the stress ball before the procedure. The patient was then taken to the angiography unit. The stress ball was placed on the palms of the patients according to the procedure position. 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. After the procedure, the NRS and STAI were filled out as a post-test 10 minutes after the patient was taken to the ward. The answers given by the patients were recorded by the researcher by marking them on the forms.

experimental group

Eligibility Criteria

• Age: 47 Years - 51 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any complication during angiography.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat Universty

Elâzığ, 23119, Turkey (Türkiye)

Location

Related Publications (1)

• Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 2024.

  PMID: 39742013 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: By drawing lots, the first set was chosen to correspond to the experimental group and the second set to correspond to the control group for the two groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This controlled randomized study

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: January 10, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 15, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)