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Completed

NCT Number: NCT05032469

Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

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.

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Key information

Conditions

Chest Tube Removal Anxiety Anxiety Disorders Heart; Surgery, Heart, Functional Disturbance as Result Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University Ankara Hospital

Ankara, Çankaya, 06490, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reflexology

Other

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

Primary outcomes

  1. Numeric Pain Rating Scale Change

    Time frame: 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

    Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)

  2. Profile of Mood States Scale Tension-Anxiety Subscale Change

    Time frame: 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

    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).

Secondary outcomes

  1. Numerical Satisfaction Evaluation Form

    Time frame: Second postoperative day

    Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)

  2. Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal

    Time frame: Second postoperative day

    Six open ended questions about the feelings and thoughts of the patients about reflexology application and chest tube removal.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Gazi University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2021
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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