The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs

May 19, 2023 updated by: Aysel Sesci
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.

Study Type

Interventional

Enrollment (Anticipated)

130

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 Contact

Study Contact Backup

Study Locations

  • Turkey
    • University
      • Aksaray, University, Turkey, 68000
        • Recruiting
        • Aysel SESCİ
        • Contact:
          • Aysel SESCİ
          • Phone Number: 03822882903

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:

  • 18 years and over
  • For those who will undergo coronary angiography for the first time
  • Able to read and write
  • Not diagnosed with anxiety disorder and not using medication for it
  • No physical disability to use the stress ball
  • Cognitive health levels consist of individuals who are suitable for answering data collection forms.

Exclusion Criteria:

  • Unconscious and not fully oriented
  • Sight and hearing problems
  • Alzheimer's disease and other types of dementia
  • Having a severe psychiatric problem that cannot answer the questions
  • Those who came with MI (myocardial infarction) and performed CAG
  • Individuals who are closed to communicating are not included in this 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress ball
Data were collected by the investigator 25-30 minutes before coronary angiography and the first measurement of vital signs was made. After the stress ball application, State Anxiety Inventory data were collected for the second time and the second measurement of vital signs was made. Vital signs were measured and noted for the third time after coronary angiography.
Other: Stress ball
Stress ball squeeze
No Intervention: Control
25-30 minutes before the coronary angiography procedure, data were collected from the patients by the investigator and the first measurements of their vital signs were recorded. Vital signs were measured a second time just before coronary angiography without any intervention. Vital signs were measured and recorded for the third time after coronary angiography ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Score
Time Frame: Change in state anxiety score within one day
Scale measuring patients' anxiety. The scores obtained from the scale vary between 20 and 80. A large score indicates high anxiety, and a small score indicates low anxiety.
Change in state anxiety score within one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Thermometer
Time Frame: Only on day 1, 2 times a day (same day).
It is a scale that measures the patient's stress level. The scale is scored between 0 and 10 points. A score of 0 indicates no stress, and a score of 10 indicates extreme stress.
Only on day 1, 2 times a day (same day).
Systolic Blood Pressure Value (mmHg)
Time Frame: Only on day 1, 2 times a day (same day).
The effect of the intervention on systolic blood pressure is examined.
Only on day 1, 2 times a day (same day).
Diastolic Blood Pressure Value (mmHg)
Time Frame: It will be measured 3 times a day (same day) on day 1 only.
The effect of the intervention on diastolic blood pressure is examined.
It will be measured 3 times a day (same day) on day 1 only.
Heart Rate/Minute Value
Time Frame: It will be measured 3 times a day (same day) on day 1 only.
The effect of the intervention on the heart rate is examined.
It will be measured 3 times a day (same day) on day 1 only.
Respiratory Rate/Minute Value
Time Frame: It will be measured 3 times a day (same day) on day 1 only.
The effect of the intervention on the respiratory rate is examined.
It will be measured 3 times a day (same day) on day 1 only.
Peripheral Oxygen Saturation (SpO2) Value
Time Frame: It will be measured 3 times a day (same day) on day 1 only.
The effect of the intervention on peripheral oxygen saturation is examined.
It will be measured 3 times a day (same day) on day 1 only.

Collaborators and Investigators

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

Sponsor

Aysel Sesci

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)

November 15, 2022

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aksaray Üniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol

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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