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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867394
• Other study ID #: Aksaray Üniversitesi
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2023
• Source: Aksaray University
• Contact: Aysel SESCI
• Phone: 2903
• Email: aysel.sesci70[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• Stress ball
Stress ball squeeze

Locations

Country	Name	City	State
Turkey	Aysel SESCI	Aksaray	University

Sponsors (1)

Lead Sponsor	Collaborator
Aysel Sesci

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety Score	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	Distress Thermometer	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).
Secondary	Systolic Blood Pressure Value (mmHg)	The effect of the intervention on systolic blood pressure is examined.	Only on day 1, 2 times a day (same day).
Secondary	Diastolic Blood Pressure Value (mmHg)	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.
Secondary	Heart Rate/Minute Value	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.
Secondary	Respiratory Rate/Minute Value	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.
Secondary	Peripheral Oxygen Saturation (SpO2) Value	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.