Clinical trial NCT05082506: Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography
Official title: Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Anxiety
Vital Signs
Coronary Angiography
Keywords: pain
anxiety
vital signs
coronary angiography
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Since the patients who will be included in the study are not known in advance, the patients will be randomized by the statistician using GraphPad software 3 and the block randomization technique, in order to assign the same number of participants to each group before the study, and will be divided into groups A, B, and C.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Acupressure application was carried out by the responsible researcher, who is certified on this subject, by TRNC Dr. In the Cardiology Service of Burhan Nalbantoğlu Hospital, patients who have undergone angiography will be applied and measurements will be made before mobilization after their informed consent is obtained.

Detailed description: In this study, it is aimed to raise awareness for the use of painless, painless, economical, side-effect-free and easy-to-apply acupressure in nursing care in order to increase patient comfort by relieving pain and anxiety of patients during mandatory bed rest after coronary angiography. In addition, our study is important in terms of providing new information with a high level of evidence and providing a source for other studies on this subject.

Objective: The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography.

Hypothesis 1 H0: There is no difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

H1: There is a difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

Hypothesis 2 H0: There is no difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

H1: There is a difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group.

Hypothesis 3 H0: There is no difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

Hypothesis 4 H0: There is no difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group.

Hypothesis 5 H0: There is no difference in Heart Rate between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Heart Rate.

Hypothesis 6 H0: There is no difference in Respiration Rate between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Respiration Rate.

Hypothesis 7 H0: There is no difference in Cortisol Level between the acupressure group, the sham (false acupressure) group and the control group.

H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Cortisol Level.

"Personal Information Form, "Spielberger State Anxiety Scale", "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be administered to all patients (acupressure, sham acupressure and control groups) included in the study (1. "Spielberger State Anxiety Inventory", "After the measurement, half an hour after applying acupressure to the points determined for both groups (2nd measurement), two hours later (3rd measurement) and just before mobilization (4th measurement)," "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be applied again.

It was created by the researcher to track the cortisol level. It is designed to include a total of 2 measurements (pre/post acupressure).

Eligibility criteria: Inclusion Criteria:

* First time coronary angiography performed
* Coronary angiography performed from the femoral region,
* over the age of 18,
* Willing to participate in the research,
* Able to understand and speak Turkish,
* Open to communication,
* Planned (non-urgent) coronary angiography
* No complications after angiography
* Stent etc. during angiography. no other attempt has been made
* No deformity or lesion in the areas where acupressure will be applied
* Not taking sedatives or pain relievers 5 hours before the angiography procedure,
* No acupressure experience
* Not diagnosed with anxiety disorder and not receiving medical treatment
* Not diagnosed with depression and not receiving medical treatment
* No chronic pain
* Patients without mental illness.

Exclusion Criteria:

* - Previous coronary angiography
* Coronary angiography from the femoral region is not performed,
* under the age of 18,
* pregnant,
* Those who do not agree to participate in the research,
* Can't understand or speak Turkish,
* Unable to communicate
* Unplanned (urgent) Coronary angiography Patients
* Any complications after angiography
* Stent etc. during angiography. another attempt has been made
* Any deformity or lesion in the areas where acupressure will be applied,
* Those who took sedatives or painkillers 5 hours before the angiography procedure,
* Experience with acupressure
* Anxiety disorder and receiving treatment,
* Diagnosed with depression and receiving treatment,
* Having chronic pain,
* Patients with mental disorders.

Primary outcomes:
measure: Spielberger State Anxiety Scale
timeFrame: 6 month
Secondary outcomes:
measure: Visual Pain Scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Selda Bal
Study officials:
References:
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