Effect of Stress Ball in Angiography

Sponsor

Firat University (Other)

Overall Status

Completed

CT.gov ID

NCT06131606

Collaborator

(none)

120

Enrollment

Location

Arms

6.1

Actual Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute	Behavioral: experimental group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This controlled randomized studyThis controlled randomized study

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

Effect of Stress Ball in Angiography: A Randomized Controlled Trial

Actual Study Start Date :

Jan 10, 2023

Actual Primary Completion Date :

Jul 10, 2023

Actual Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: control group No intervention other than the clinic protocol was applied to this group.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

47 Years to 51 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Firat Universty	Elazığ		Turkey	23119

Sponsors and Collaborators

Firat University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dilek Güneş, Assistant Professor, Firat University

ClinicalTrials.gov Identifier:

NCT06131606

Other Study ID Numbers:

FU-SN-DG-01

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dilek Güneş, Assistant Professor, Firat University

Additional relevant MeSH terms:

Acute Pain

Study Results

No Results Posted as of Nov 14, 2023