Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial

In open heart surgeries, patients experience severe pain due to tissue trauma, damage to intercostal nerves, and muscle spasm due to pulling tubes from the mediastinal space and between the pleural leaves pull during chet tube removal (CTR). When acute pain is not relieved, the patient develops emotional, psychological (eg post-traumatic stress disorder) and physical problems (eg chronic pain) after surgery. Since this situation negatively affects the healing process, it increases the anxiety level of the patients and decreases the comfort level. Reflexology is one of the non-pharmacological methods used in the management of pain and anxiety after open heart surgery The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level. This study will be done a randomized-controlled trial to test the intervention.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Chest Tube Removal; Heart; Surgery, Heart, Functional Disturbance as Result
• Intervention / Treatment: Other: Reflexology

Detailed Description

Background: Patients undergoing cardiovascular surgery suffer from anxiety and pain due to the chest tube removal (CTR).

Objective/Hypothesis: The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level.The following hypotheses (H) were tested in this study:

H1a : There was a difference between the reflexology group and the control group in terms of pain level during CTR.

H1b : There was a difference between the reflexology group and the control group in terms of anxiety level during CTR.

H1c : There was a difference between the reflexology group and the control group in terms of the difference between the pain level before CTR and during CTR.

H1d : There was a difference between the reflexology group and the control group in terms of the difference between the anxiety level before CTR and during CTR.

Study design: A randomized controlled trial. Method: The study sample who has gone through coronary artery bypass graft surgery was randomly assigned to reflexology or the control group (twenty- eight each in). The primary outcomes were pain, evaluated using a numeric pain-rating scale, and anxiety evaluated by the profile of mood states scale tension-anxiety subscale, both measured first (before and after reflexology) and second postoperative days (before the reflexology and immediately after chest tube removal, 15th minutes and 1 h).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06490
      • Baskent University Ankara Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients over 18 years who have CABG surgery
• Having at least two chest tube catheters
• Having chest tubes removed together
• Volunteering to participate in the research

Exclusion Criteria:

• Patients with diagnosed with psychiatric illness
• Having orientation or confusion problems, complete vision or hearing loss, mental problems due to problems such as dementia, mental retardation, and language problems
• Having pacemaker, varicose veins in the ankles
• Having chronic pain
• Having femoral fracture and open wound on the sole of the foot
• Having acute infection and hyperthermia, thromboembolism, suspected deep vein thrombosis at the postoperatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refloxology Intervention; The first foot reflexology was applied to the intervention group for 30 min (20 min on the right foot, 10 min on the left foot) on the first postoperative day (24 h after the surgery). On the second postoperative day, 30 min of foot reflexology was applied to the patients who decided to chest tube removal (CTR). After the foot reflexology applied by the researcher, CTR was performed by the doctor within 10 min. Immediately after CTR, the patient's pain and anxiety level during CTR was measured. At the 15th minute after CTR, the pain and anxiety level of the patients was measured, their satisfaction with the reflexology application was measured. Then, the patients were asked to describe the pain and feelings and thoughts during CTR, 1 hr after CTR, pain level was measured, and they were asked to express their feelings and thoughts about the reflexology application.	Other: Reflexology; Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet
No Intervention: Standart Care; Participants in the control group will receive standart postoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale Change	Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)	1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min,1h after chest tube removal
Profile of Mood States Scale Tension-Anxiety Subscale Change	Profile of Mood States Scale Tension-Anxiety Subscale includes the following nine items: tense, shaky, on edge, panicky, uneasy, restless, nervous and anxious. Each item was graded as 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit) or 4 (extremely) and the sum of the items is the total scale, varying from 0 (no tension-anxiety) - 36 (most tension-anxiety).	1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min after chest tube removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Satisfaction Evaluation Form	Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)	Second postoperative day
Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal	Six open ended questions about the feelings and thoughts of the patients about reflexology application and chest tube removal.	Second postoperative day

Collaborators and Investigators

• Sponsor: Baskent University
• Collaborators: Gazi University
• Investigators: Principal Investigator: Elif BUDAK ERTÜRK, MsN,RN, PhD, Başkent University, Faculty of Health Science, Department of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Nursing; Reflexology; Cardiac surgery; Chest tubes
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 24074710-38

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