Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography

Pain Clinical Trial

Official title:

Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05082506
• Other study ID #: 41/21
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Eastern Mediterranean University
• Contact: SELDA BAL, 1
• Phone: +905338717636
• Email: selda.bal[@]emu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Coronary Angiography
• Pain
• Vital Signs

Intervention

Behavioral:
• Acupressure
Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief.

Locations

Country	Name	City	State
Cyprus	Selda Bal	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (9)

Au DW, Tsang HW, Ling PP, Leung CH, Ip PK, Cheung WM. Effects of acupressure on anxiety: a systematic review and meta-analysis. Acupunct Med. 2015 Oct;33(5):353-9. doi: 10.1136/acupmed-2014-010720. Epub 2015 May 22. — View Citation

Caldwell PH, Arthur HM, Natarajan M, Anand SS. Fears and beliefs of patients regarding cardiac catheterization. Soc Sci Med. 2007 Sep;65(5):1038-48. Epub 2007 May 15. — View Citation

Fereidouni Z, Kameli Morandini M, Najafi Kalyani M. The efficacy of interventions for back pain in patients after transfemoral coronary angiography: A rapid systematic review. J Vasc Nurs. 2019 Mar;37(1):52-57. doi: 10.1016/j.jvn.2018.11.002. Epub 2018 De — View Citation

Khoram B, Yoosefinejad AK, Rivaz M, Najafi SS. Investigating the Effect of Acupressure on the Patients' Anxiety Before Open-Heart Surgery: A Randomized Clinical Trial. J Acupunct Meridian Stud. 2020 Dec;13(6):169-173. doi: 10.1016/j.jams.2020.11.001. Epub — View Citation

Sharif F, Najafi Kalyani M, Ahmadi F, Iman MT. In the shadow of perceived threat: The live experience of Iranian patients candidate for undergoing coronary angiography. J Vasc Nurs. 2018 Sep;36(3):140-144. doi: 10.1016/j.jvn.2018.04.004. Epub 2018 Jun 7. — View Citation

Sharifi Rizi M, Shamsalinia A, Ghaffari F, Keyhanian S, Naderi Nabi B. The effect of acupressure on pain, anxiety, and the physiological indexes of patients with cancer undergoing bone marrow biopsy. Complement Ther Clin Pract. 2017 Nov;29:136-141. doi: 1 — View Citation

Shoulders-Odom B. Management of patients after percutaneous coronary interventions. Crit Care Nurse. 2008 Oct;28(5):26-41; quiz 42. Review. — View Citation

Tolentino JC, Schmidt JJ, Schmidt GJ, Mesquita CT, Schmidt SL. Mental Stress-Induced Myocardial Ischemia Related to Generalized Anxiety Disorder in a Patient With Acute Coronary Syndrome and Normal Coronary Arteries. Clin Nucl Med. 2016 Nov;41(11):e487-e4 — View Citation

Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spielberger State Anxiety Scale	The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.	6 month
Secondary	Visual Pain Scale	It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the patient is very good and the other end is very bad.	6 month