Clinical trial NCT05032469: Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal
Official title: Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tube Removal
Heart; Surgery, Heart, Functional Disturbance as Result
Pain
Anxiety
Keywords: Anxiety
Cardiac surgery
Chest tubes
Nursing
Pain
Reflexology
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2021-09-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale Change
timeFrame: 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
measure: Profile of Mood States Scale Tension-Anxiety Subscale Change
timeFrame: 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 outcomes:
measure: Numerical Satisfaction Evaluation Form
timeFrame: Second postoperative day
measure: Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal
timeFrame: Second postoperative day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
state: Çankaya
Study officials:
affiliation: Başkent University, Faculty of Health Science, Department of Nursing
name: Elif BUDAK ERTÜRK, MsN,RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: