Stress Ball Use in Patients Undergoing Coronary Angiography

July 5, 2024 updated by: Sumeyye Akcoban, Mustafa Kemal University

The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography

One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in the cardiology clinics of a state hospital between April 2024 and June 2024. The study was planned as a randomized experimental study to examine the effect of stress ball use on immobilization comfort, pain level and vital signs in patients undergoing coronary angiography. The population of the study consisted of patients admitted to the cardiology clinic of a state hospital. G*Power 3.1.9.7 program was used for sample size calculation. Cohen's standardized effect size was used since no study with similar sample characteristics and criteria was found. Friedman's F Test was used to evaluate whether the effect on immobilization comfort, pain level and vital signs differed between the intervention and control groups of patients undergoing angiography through the femoral artery. Accordingly, the sample size was determined as (n=66), intervention group (n=33), control group (n=33) with a low effect size (0.2) in line with the relevant tests and a pyori calculation with α error=0.05, (1-β error) =0.95. A total of 72 patients, 36 in each group, were planned to be included in the study with a 10% patient loss. The patient information form prepared by the investigators will be filled in before transfer to the angiography procedure room for the patients who were determined as intervention (n=36) and control group (n=36). Data will be evaluated in 3 stages: 2 hours before sheath extraction, 2 hours after sheath extraction and 4 hours after sheath extraction. The researchers will explain and demonstrate to the intervention group how to use the stress ball. Then, the patient will be asked to use the ball and it will be confirmed whether they use it correctly. After angiography, it will be stated that the patients in the intervention group should count to 5 and squeeze it once for 10 minutes every hour and rotate with the right and left hand until they are mobilized. The stress ball used will be of medium hardness and made of high quality silicone. Stress balls will be provided by the researchers and given to the patients. Patients in the control group will not undergo any intervention. Comfort level, vital signs and pain will be evaluated with Immolization comfort scale 2 hours before Sheath extraction. Pain and vital signs will be evaluated 2 hours after Sheath extraction and comfort level, vital signs and pain will be evaluated with Immolization comfort scale 4 hours after Sheath extraction.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Hatay, Turkey
        • Hatay Mustafa Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Who are over 18 years old,
  • Having no barriers to written and verbal communication in Turkish,
  • Patients without chronic dermatological and/or vascular disease
  • Patients undergoing angiography via the femoral artery will be included in the trial

Exclusion Criteria:

  • Patients who cannot communicate verbally
  • Patients with a psychiatric diagnosis
  • Patients who drop out of the study at any stage of the study
  • Patients who underwent angiography using an artery other than the femoral artery will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

Intervention Group Patients in the intervention group will be allowed to use a stress ball. The comfort level, vital signs and pain intensity of the patients in the intervention group will be evaluated with the Immolization comfort scale 2 hours before Sheath extraction. Pain intensity and vital signs will be evaluated 2 hours after sheath extraction, and comfort level, vital signs and pain intensity will be evaluated with Immolization comfort scale 4 hours after sheath extraction.

Stress Ball Use Practice for the Intervention Group The researchers will explain and demonstrate to the intervention group how to use the stress ball. Then, the patient will be asked to use the ball and it will be confirmed whether he/she uses it correctly. After angiography, it will be stated that the patients in the intervention group should count to 5 and squeeze it once for 10 minutes every hour and rotate with the right and left hand until they are mobilized.
Device: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography
The researchers will explain and demonstrate to the intervention group how to use the stress ball. Then, the patient will be asked to use the ball and it will be confirmed whether he/she uses it correctly. After angiography, it will be stated that the patients in the intervention group should count to 5 and squeeze it once for 10 minutes every hour and rotate with the right hand and left hand until they are mobilized.
No Intervention: Control Group
Control Group Patients in the control group will not undergo any intervention. Comfort level, vital signs and pain will be evaluated with Immolization comfort scale 2 hours before Sheath extraction. Pain and vital signs will be evaluated 2 hours after Sheath extraction and comfort level, vital signs and pain will be evaluated with Immolization comfort scale 4 hours after Sheath extraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immobilization Comfort Scale
Time Frame: Comfort assessment with Immobilization Comfort Scale will be performed 2 hours before, 2 hours and 4 hours after sheath extraction.
The Turkish validity and reliability study of the scale developed by Hogan-Miller in 1995 was conducted. The scale consists of 20 items. Each statement in the scale has a Likert-type scoring ranging from 1-6 from "strongly disagree" to "strongly agree". Items 2, 3, 4, 7, 8, 10, 13, 14 and 18 in the scale are negative statements. The total scores obtained from the scale vary between 20 and 120, with a high score indicating good comfort. Cronbach's alpha value of the scale was found to be 0.82.
Comfort assessment with Immobilization Comfort Scale will be performed 2 hours before, 2 hours and 4 hours after sheath extraction.
Visual Benchmarking Scale
Time Frame: Pain assessment will be performed with Visual Comparison Scale 2 hours before, 2 hours and 4 hours after sheath extraction.
The scale allows patients to measure their own pain level by marking their pain level on a 10 cm ruler at intervals ranging from "no pain" to "most severe pain". The scale has been reported to be more sensitive and reliable than other unidimensional scales in measuring pain level. A study was conducted to standardize this scale and it was found that the vertical use of the scale was better understood by patients. In this model, the patient is told that "the scale has two endpoints and he/she is free to mark any point between these points that corresponds to his/her pain level". The interval between the "pain-free" point and the point marked by the patient is recorded in centimeters using a ruler.
Pain assessment will be performed with Visual Comparison Scale 2 hours before, 2 hours and 4 hours after sheath extraction.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nurse Observation Form
Time Frame: 2 hours before the sheath extraction, 2 hours and 4 hours after the sheath extraction; vital signs will be evaluated with the vital signs recorded on the Nurse Observation Form.
Vital signs (Blood Pressure, Pulse, Temperature, Respiration and Partial Oxygen Pressure) will be taken from the nurse observation form recorded every hour.
2 hours before the sheath extraction, 2 hours and 4 hours after the sheath extraction; vital signs will be evaluated with the vital signs recorded on the Nurse Observation Form.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Benchmarking Scale
Time Frame: This form will be applied separately to patients with and without intervention. The evaluation will be done in 3 stages: 2 hours before Sheth extraction, 2 hours after Sheath extraction and 4 hours after Sheath extraction.
The scale allows patients to measure their own pain level by marking their pain level on a 10 cm ruler at intervals ranging from "no pain" to "most severe pain". The scale has been reported to be more sensitive and reliable than other unidimensional scales in measuring pain level. Cline et al. carried out a study to provide standardization in the IAS and found that the vertical use of the IAS was better understood by patients. In this model, the patient is told that "the scale has two endpoints and that he/she is free to mark any point between these points that matches his/her pain level". The interval between the "pain-free" point and the point marked by the patient is recorded in centimeters using a ruler.
This form will be applied separately to patients with and without intervention. The evaluation will be done in 3 stages: 2 hours before Sheth extraction, 2 hours after Sheath extraction and 4 hours after Sheath extraction.
Vital Signs Monitoring Form
Time Frame: This form will be applied separately to patients with and without intervention. The evaluation will be done in 3 stages: 2 hours before Sheth extraction, 2 hours after Sheath extraction and 4 hours after Sheath extraction.
Vital signs (Blood Pressure, Pulse, Temperature, Respiration and SpO2) are recorded on the nurse observation form every hour. Therefore, vital signs will be taken from the nurse observation form.
This form will be applied separately to patients with and without intervention. The evaluation will be done in 3 stages: 2 hours before Sheth extraction, 2 hours after Sheath extraction and 4 hours after Sheath extraction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemal University

Investigators

  • Principal Investigator: SÜMEYYE AKÇOBAN, Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMKU-KMY-SA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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