- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300294
Acute Coronary Syndrome and Acupressure
Effect of Acupressure on Anxiety, Pain and Vital Signs in Individuals Diagnosed With Acute Coronary Syndrome: A Randomized Controlled Study
This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS).
H1-1: Acupressure applied to individuals diagnosed with ACS has an effect on the level of anxiety.
H1-2: Acupressure applied to individuals diagnosed with ACS has an effect on blood pressure.
H1-3: Acupressure applied to individuals diagnosed with ACS has an effect on heart rate.
H1-4: Acupressure applied to individuals diagnosed with ACS has an effect on respiratory rate.
H1-5: Acupressure applied to individuals diagnosed with ACS has an effect on the pain level.
H1-6: Acupressure applied to individuals diagnosed with ACS has an effect on cortisol levels.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: saadet can çiçek, Dr
- Phone Number: 05062846936
- Email: saadet.cancicek@ibu.edu.tr
Study Contact Backup
- Name: hospital Chief physician, Dr
- Phone Number: 0 236 229 26 00
- Email: manisasehir@saglik.gov.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Volunteer to participate in the study,
- Those aged 18 and over
- Able to speak Turkish
- Diagnosed with ACS for the first time
- Cardiopulmonary resuscitation not applied
- No orientation problems (those who score 15 on the Glasgow Coma Scale)
- Not diagnosed with psychiatric disease
- No amputation, fistula, lymphedema, neuropathy or hemiplegia in any of the Upper Extremities
- Those who underwent femoral intervention for CAG procedure
- Those who have not used any integrative practices based on pressure and stimulation such as acupressure, acupuncture and reflexology in the last month.
- Vital signs (28) are within normal range:
Blood pressure: 90/60-120/80 mmHg Heart rate: 60-100 min Respiratory rate: 12-18 min
Exclusion Criteria:
- Those with arrhythmia (AF, VT etc.)
- Patients who have previously undergone Coronary Angiography
- Diagnosed with myocarditis, pericarditis
- Those who do not take any speed-breaking drugs (beloc, arlec, etc.).
- Patients who underwent radial intervention for CAG procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acupressure
acupressure application and Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).
|
After the CAG procedure, acupressure will be applied to individuals whose vital signs are within the normal range.
|
No Intervention: control
Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
means of blood pressure
Time Frame: up to 30 minutes
|
In this study, blood pressure was measured using monitors in the intensive care unit.
|
up to 30 minutes
|
means of hear rate
Time Frame: up to 30 minutes
|
Heart rate is the pressure exerted on the vessel wall by the blood thrown by the left ventricle from the skin surface to the aorta during systole.
In the research, heart rate is measured using a monitor.
|
up to 30 minutes
|
means of respiratory rate
Time Frame: up to 30 minutes
|
Respiratory rate is the patient's breaths per minute.
In this study, respiratory rate was taken from the monitor.
|
up to 30 minutes
|
means of cortisol.
Time Frame: up to 60 minutes
|
The cortisol value in the blood will be measured.
|
up to 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
means of subjective anxiety scores.
Time Frame: up to 30 minutes
|
numerical anxiety scale.
The total score between 0-10 obtained.
|
up to 30 minutes
|
means of subjective pain scores.
Time Frame: up to 30 minutes
|
visual analog scale.
It consists of a straight line with endpoints that define end limits such as "no pain" and "pain as bad as possible".
The patient is asked to mark the level of pain on the line between the two endpoints.
|
up to 30 minutes
|
electrocardiography evaluation
Time Frame: up to 30 minutes
|
Electrocardiography is the process of recording the electrical activity occurring in the heart to examine the functioning of the heart muscle and neural conduction system.
|
up to 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: aynur açıkgöz, PhD student, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-SBF-AYN-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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