- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473287
The Effect of Reflexology After Coronary Artery Bypass Graft Surgery
July 5, 2021 updated by: Elif Gezginci, Saglik Bilimleri Universitesi
The Effect of Reflexology Applied to Patients Undergoing Coronary Artery Bypass Graft Surgery on Pain, Anxiety, Fatigue and Sleep: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Sağlık Bilimleri University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: intervention group
Reflexology was applied to the intervention group during the procedure for 45 minutes.
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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.
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No Intervention: control group
Reflexology was not applied to the control group during the procedure.
The control group received standard care and treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on pain intensity as measured by Visual Analog Scale
Time Frame: ''just before procedure'' and ''30 minutes after procedure''
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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.
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''just before procedure'' and ''30 minutes after procedure''
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Change on fatigue intensity as measured by Visual Analog Scale
Time Frame: ''just before procedure'' and ''30 minutes after procedure''
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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.
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''just before procedure'' and ''30 minutes after procedure''
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score change on anxiety level as measured by State-Trait Anxiety Inventory
Time Frame: ''just before procedure'' and ''30 minutes after procedure''
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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.
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''just before procedure'' and ''30 minutes after procedure''
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Score change on sleep quality as measured by Richard's Campbell Sleep Scale
Time Frame: ''just before procedure'' and ''30 minutes after procedure''
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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.
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''just before procedure'' and ''30 minutes after procedure''
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elif Gezginci, RN, PhD, Sağlık Bilimleri Üniversitesi, Turkey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.
- 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 Pract. 2018 May;31:220-228. doi: 10.1016/j.ctcp.2018.02.018. Epub 2018 Mar 3.
- 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 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 16, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-10/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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