The Effect of Reflexology After Coronary Artery Bypass Graft Surgery

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT04473287
Collaborator
(none)
70
1
2
9.9
7.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: reflexology practice
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

Reflexology was applied to the intervention group during the procedure for 45 minutes.

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.

No Intervention: control group

Reflexology was not applied to the control group during the procedure. The control group received standard care and treatment.

Outcome Measures

Primary Outcome Measures

  1. Change on pain intensity as measured by Visual Analog Scale [''just before procedure'' and ''30 minutes after procedure'']

    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.

  2. Change on fatigue intensity as measured by Visual Analog Scale [''just before procedure'' and ''30 minutes after procedure'']

    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.

Secondary Outcome Measures

  1. Score change on anxiety level as measured by State-Trait Anxiety Inventory [''just before procedure'' and ''30 minutes after procedure'']

    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.

  2. Score change on sleep quality as measured by Richard's Campbell Sleep Scale [''just before procedure'' and ''30 minutes after procedure'']

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sağlık Bilimleri University Istanbul Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Elif Gezginci, RN, PhD, Sağlık Bilimleri Üniversitesi, Turkey

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Elif Gezginci, RN, PhD, Asst Prof., Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT04473287
Other Study ID Numbers:
  • 2020-10/35
First Posted:
Jul 16, 2020
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Gezginci, RN, PhD, Asst Prof., Saglik Bilimleri Universitesi

Study Results

No Results Posted as of Jul 7, 2021