Back to resultsThe Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stress ball
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary angiography, stress, anxiety, vital signs
Eligibility Criteria
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.
Sites / Locations
- Aysel SESCİRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stress ball
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Systolic Blood Pressure Value (mmHg)
The effect of the intervention on systolic blood pressure is examined.
Diastolic Blood Pressure Value (mmHg)
The effect of the intervention on diastolic blood pressure is examined.
Heart Rate/Minute Value
The effect of the intervention on the heart rate is examined.
Respiratory Rate/Minute Value
The effect of the intervention on the respiratory rate is examined.
Peripheral Oxygen Saturation (SpO2) Value
The effect of the intervention on peripheral oxygen saturation is examined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05867394
Brief Title
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Official Title
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aysel Sesci
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary angiography, stress, anxiety, vital signs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Prospective Randomized Controlled Clinical Trial
Masking
Participant
Masking Description
Participants do not know which group they are in.
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress ball
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stress ball
Intervention Description
Stress ball squeeze
Primary Outcome Measure Information:
Title
State Anxiety Score
Description
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.
Time Frame
Change in state anxiety score within one day
Secondary Outcome Measure Information:
Title
Distress Thermometer
Description
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.
Time Frame
Only on day 1, 2 times a day (same day).
Title
Systolic Blood Pressure Value (mmHg)
Description
The effect of the intervention on systolic blood pressure is examined.
Time Frame
Only on day 1, 2 times a day (same day).
Title
Diastolic Blood Pressure Value (mmHg)
Description
The effect of the intervention on diastolic blood pressure is examined.
Time Frame
It will be measured 3 times a day (same day) on day 1 only.
Title
Heart Rate/Minute Value
Description
The effect of the intervention on the heart rate is examined.
Time Frame
It will be measured 3 times a day (same day) on day 1 only.
Title
Respiratory Rate/Minute Value
Description
The effect of the intervention on the respiratory rate is examined.
Time Frame
It will be measured 3 times a day (same day) on day 1 only.
Title
Peripheral Oxygen Saturation (SpO2) Value
Description
The effect of the intervention on peripheral oxygen saturation is examined.
Time Frame
It will be measured 3 times a day (same day) on day 1 only.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysel SESCİ
Phone
2903
Ext
0382288
Email
aysel.sesci70@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kadriye SAYIN KASAR
Phone
2785
Ext
0382288
Email
kadriyekasar@aksaray.edu.tr
Facility Information:
Facility Name
Aysel SESCİ
City
Aksaray
State/Province
University
ZIP/Postal Code
68000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysel SESCİ
Phone
03822882903
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol
Learn more about this trial
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
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