NCT04473287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

July 14, 2020

Last Update Submit

July 5, 2021

Conditions

Coronary Artery Bypass Graft Surgery

Keywords

reflexology, pain, anxiety, fatigue, sleep

Outcome Measures

Primary Outcomes (2)

  • 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''

  • 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 Outcomes (2)

  • Score change on anxiety level as measured by State-Trait Anxiety Inventory

    ''just before procedure'' and ''30 minutes after procedure''

  • Score change on sleep quality as measured by Richard's Campbell Sleep Scale

    ''just before procedure'' and ''30 minutes after procedure''

Study Arms (2)

intervention group

EXPERIMENTAL

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

Other: reflexology practice

control group

NO INTERVENTION

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

Interventions

reflexology practiceOTHER

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 24439644RESULT

  • 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.

    PMID: 29705459RESULT

  • 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.

    PMID: 20561864RESULT

Related Links

MeSH Terms

Conditions

PainAnxiety DisordersFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Elif Gezginci, RN, PhD

    Sağlık Bilimleri Üniversitesi, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Asst Prof.

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 16, 2020

Study Start

September 1, 2020

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)