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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Other: Stress ball

• Registration Number: NCT05867394
• Lead Sponsor: Aysel Sesci

Brief Summary

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

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 Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2023-02-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress ball	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.

Primary Outcome Measures

Name	Time	Method
State Anxiety Score	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.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure Value (mmHg)	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.
Distress Thermometer	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.
Systolic Blood Pressure Value (mmHg)	Only on day 1, 2 times a day (same day).	The effect of the intervention on systolic blood pressure is examined.
Peripheral Oxygen Saturation (SpO2) Value	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.
Heart Rate/Minute Value	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.
Respiratory Rate/Minute Value	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.

Trial Locations

Locations (1)

Aysel SESCİ; 🇹🇷 Aksaray, University, Turkey