The Effect of Reflexology After Coronary Artery Bypass Graft Surgery

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

The Effect of Reflexology Applied to Patients Undergoing Coronary Artery Bypass Graft Surgery on Pain, Anxiety, Fatigue and Sleep: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473287
• Other study ID #: 2020-10/35
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary artery bypass graft (CABG) surgery is a treatment method that increases survival rate in the treatment of coronary artery disease (CAD). CABG surgery can create anxiety, fear, pain, fatigue, sleep disorders and physiological dysfunctions in patients. Nurses responsible for the care and treatment of patients use pharmacological and non-pharmacological methods to alleviate the problems that arise. In this context, reflexology within complementary and alternative therapy (CAM) can be applied. In this study, it is aimed to evaluate the effect of reflexology applied to patients undergoing coronary artery bypass graft surgery on pain, anxiety, fatigue, sleep and physiological parameters.

Description:

In the literature, there are a limited number of studies on the effect of reflexology applied on patients undergoing CABG surgery on anxiety and physiological parameters. In addition, no studies on the effect of reflexology on sleep on patients undergoing CABG surgery have been encountered. Anxiety, stress, pain, fatigue, sleep disorders and permanent symptoms may occur in individuals after cardiovascular surgery. It has been determined that with the deterioration in the body system functions and the resulting psychological problems, the blood pressure, heart rhythm and the number of breaths in the individual, respiratory and coughing difficulties due to pain inactivity, body temperature changes, muscle tension, fatigue and even death can occur. With the application of reflexology, the work of the body systems is regulated by providing homeostasis, physiological and psychological relaxation and relaxation are felt with the energy flow that occurs in the body, and toxins are removed from the body. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters. The population of the study will be the patients who underwent CABG surgery in the Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic of Uludağ University Health Practice and Research Center Hospital. The sample will be composed of patients undergoing CABG surgery in Uludag University Health Practice and Research Center Hospital Cardiovascular Surgery Department Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic that meet the inclusion criteria. Data will be collected using Personal Information Form, Physiological Parameters Control Form, Visual Analogue Scale, State Anxiety Scale, Richard's Campbell Sleep Scale. The data obtained from the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, average and standard deviation will be used as descriptive statistical methods in the evaluation of the data. The t-test will be used to compare quantitative continuous data between two independent groups. Differences between repeated measurements will be analyzed by repeated measurements ANOVA test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65

• Having undergone CABG surgery for the first time

• CABG has not been operated in an emergency

• Lack of reflexology history

• Not taking inotropic drugs At least 4 hours have passed since the application of the last analgesic drug

• Mental insufficiency and no vision, hearing impairment

• Place, time and person orientation

• Psychological treatment and drug use for this purpose

• Participants agree to participate in the research

Exclusion Criteria:

• Decreased level of consciousness

• Valve repair or replacement during CABG surgery Need for intraaortic balloon and pacemaker

• Drainage over 200 ml per hour

• Having a history of chronic pain

• Being addicted to alcohol and drugs

• Bone fractures, sensory disorders, skin infections, skin ulcers in the feet

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery

Intervention

Other:
• reflexology practice
Reflexology is a reliable and holistic complementary and alternative treatment method that means that the body's specific glands, organs and regions are stimulated by applying a special pressure with the fingers on the hands, feet and ears. When the literature is analyzed, it has been determined that reflexology is applied effectively before, during and after surgery, including different surgical procedures, and it is emphasized that one of the most important areas is patients who underwent Coronary Artery Bypass Graft (CABG) surgery. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Abbaszadeh Y, Allahbakhshian A, Seyyedrasooli A, Sarbakhsh P, Goljarian S, Safaei N. Effects of foot reflexology on anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery: A clinical trial. Complement Ther Clin Pr — View Citation

Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. — View Citation

Tully PJ, Bennetts JS, Baker RA, McGavigan AD, Turnbull DA, Winefield HR. Anxiety, depression, and stress as risk factors for atrial fibrillation after cardiac surgery. Heart Lung. 2011 Jan-Feb;40(1):4-11. doi: 10.1016/j.hrtlng.2009.12.010. Epub 2010 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on pain intensity as measured by Visual Analog Scale	The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.	''just before procedure'' and ''30 minutes after procedure''
Primary	Change on fatigue intensity as measured by Visual Analog Scale	The average score change on fatigue intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure fatigue intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that fatigue intensity is high.	''just before procedure'' and ''30 minutes after procedure''
Secondary	Score change on anxiety level as measured by State-Trait Anxiety Inventory	The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.	''just before procedure'' and ''30 minutes after procedure''
Secondary	Score change on sleep quality as measured by Richard's Campbell Sleep Scale	The average score change on sleep quality as measured by Richard's Campbell Sleep Scale. This scale in used to measure sleep quality. The scores on the scale ranges from 0 to 100. The high scores on the scale indicate that sleep quality is high.	''just before procedure'' and ''30 minutes after procedure''

External Links

•   An Alternative Method for Labor Pain: Foot Reflexology
•   The Effects of Foot Reflexology Massage on Pain and Fatigue of Patients After Coronary Artery Bypass Graft