Effect of Stress Ball in Angiography

NCT ID: NCT06131606

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-07-15

Brief Summary

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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

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This controlled randomized study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

experimental group

Intervention Type 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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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experimental group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

47 Years

Maximum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Firat University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Güneş

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Firat Universty

Elâzığ, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39742013 (View on PubMed)

Other Identifiers

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FU-SN-DG-01

Identifier Type: -

Identifier Source: org_study_id

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