Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032469
• Other study ID #: 24074710-38
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: November 25, 2020

Study information

• Verified date: July 2023
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 25, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chest Tube Removal
• Heart; Surgery, Heart, Functional Disturbance as Result
• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Baskent University Ankara Hospital	Ankara	Çankaya

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Numerical Satisfaction Evaluation Form	Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)	Second postoperative day
Secondary	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