TITLE:

“THE EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) VS SLOW DEEP BREATHING RELAXATION EXERCISE (SDBRE) ON PAIN LEVELS DURING AND POST CHEST TUBE REMOVAL AFTER CORONARY ARTERY BYPASS GRAFT SURGERY - AN EXPERIMENTAL STUDY”

Under the guidance

 Dr. Deepak Jain. N (MPT)

 Assistant  Professor, Narayana Hrudayalaya Institute of Physiothersapy.

Investigator

Srimonta Das

MPT, Narayana Hrudayalaya Institute of Physiotherapy

PROJECT SUMMARY

The aim of the study to find out the effectiveness of Transcutaneous electrical nerve stimulation (TENS) along with slow deep breathing relaxation exercise (SDBRE) on pain levels during and post chest tube removal after coronary artery bypass graft surgery. With the sample size of thirty eight (38) post CABG patients. The Visual analogue scale (VAS) will be use as an outcome measures. The time of the assessment will be taken before the treatment started. With between-groups experimental design and random patient allocation will be into two groups

The hypotheses of the study can be outlined as:

 Hypothesis-

Null Hypothesis [H0]:

There will be no significant difference of transcutaneous electrical nerve stimulation (TENS) compared to of slow deep breathing relaxation exercise (SDBRE) on pain levels during and post chest tube removal after coronary artery bypass graft surgery.

Alternate Hypothesis [H1]:

There will be significant difference of Transcutaneous electrical nerve stimulation (TENS) compared to of slow deep breathing relaxation exercise (SDBRE) on pain levels during and post chest tube removal after coronary artery bypass graft surgery.

INTRODUCTION AND NEED FOR THE STUDY:

Introduction:

Coronary artery bypass graft surgery (CABG) is a procedure used to treat coronary artery disease. Coronary artery disease (CAD) is the narrowing of the coronary arteries caused by a build-up of fatty material within the walls of the arteries .The traditional “open heart” procedure is commonly done and often preferred in many situations; less invasive techniques such as “Off-pump” procedure have been developed to bypass blocked coronary arteries.

During CABG surgery, the surgeon uses a portion of a healthy vessel (either an artery or vein) from the leg, chest, or arm to create a bypass around the clogged artery. Patients typically receive 1 to 5 bypasses per operation depending on how many coronary arteries (and their main branches) are blocked .

Immediately following CABG surgery, the patient is transferred to the intensive care unit (ICU) and is monitored through various medical devices, including electrocardiogram monitors, arterial and central lines, ventilators, and chest tubes.

Chest tubes are inserted into the pleural or mediastinal spaces after CABG surgery to remove fluid, air, and pus from the chest cavity and prevent potential cardiopulmonary complications.

Pain experienced during CTR can result in deleterious neuro hormonal and physiologic responses.   In turn, this stimulates catecholamines release and the activation of the sympathetic nervous system, causing hypertension, tachycardia, tachypnoea and increased cardiac oxygen utilization. As a result, these changes may lead to left ventricular dysfunction and myocardial ischemia.

 Moreover, pain post CABG surgery can lead to poor inspiratory efforts, which may contribute to postoperative pulmonary complications and ultimately compensate the health outcomes. Moreover, unrelieved pain can trigger the hormonal stress response. This involves glucagon and cortisol release, associated with insulin resistance and hyperglycemia .

However, ICU patients have reported chest tube removal (CTR) as an extremely painful and stressful procedure.

Therefore, more focus needs to be placed on providing adequate pain management and preventing undesired outcomes.

Transcutaneous electrical nerve stimulation (TENS) has been used as an adjunctive therapy for chronic and acute pain control. It has also been shown to be effective to reduce pain in the post operative period of cardiac and non-cardiac thoracic surgery. It is a form of electrical stimulation with surface electrodes which are used to modulate pain perception.

Within the last two’ three decades, there have been increasing numbers of reports concerning the use of Transcutaneous electrical nerve stimulation (TENS) for postoperative pain relief. TENS has been found effective for postoperative pain relief after various surgeries such as gynecological and thoracic operations. 

SDBRE is among the simplest relaxation techniques uses in managing pain experienced by patients during CTR. It is also a non-invasive, inexpensive, time-saving, risk-free and pain-relieving 5 to 15-min technique that involves inhaling air through the nose and exhaling it slowly with the lips semi-closed (pursed-lip exercise) .

Need for the study:

  Pain experienced during CTR can result in deleterious neurohormonal and physiologic responses. In turn, this stimulates catecholamines release and the activation of the sympathetic nervous system, causing hypertension, tachycardia, tachypnoea, and increased cardiac oxygen utilization. A number of lung defence mechanisms may become impaired, or overtly ineffective due to intense pain. Although narcotics and opiates may be effective for pain control, they are associated with side effect including respiratory depression. Therefore, there is a long-standing interest in the development of non-chemical strategies for effective pain control.

LACUNAE IN LITERATURE: 

As evident from above review of literature, currently, there is a lack of research regarding effectiveness of TENS to reducing the pain in patients with ICD in CABG surgery. Although individually these techniques show reducing pain and improving functional capacity, but there is a lack of comparative study to find which technique is better. Thus, further high-quality studies like RCTs need to be performed. Realizing this need, the current study has been proposed.

RESEARCH QUESTION:

Is either Transcutaneous electrical nerve stimulation or Slow deep breathing exercise are effective on ICD removal pain in patient with CABG surgery?

 AIMS AND OBJECTIVES

 AIM:

To determine the effect of Transcutaneous electrical nerve stimulation (TENS) vs   slow deep breathing relaxation exercise (SDBRE) on pain levels during and post chest tube removal after coronary artery bypass graft surgery.

OBJECTIVES:

PRIMARY OBJECTIVE-

 To assess the level of pain during and after CTR in group A (TENS) and group B (SDBRE)

SECONDARY OBJECTIVE-

 To compare the pain reduction between the group A (TENS) and group B (SDBRE) after CTR at post assessment

MATERIAL AND METHODS

Study area:  Adult intensive treatment unit , Narayana institute of cardiac sciences,                 

Bangalore

Study  design  : Experimental study

Study population : Subject with intercostals drainage tube after CABG surgery

Sample size: 38 participants

Method of blinding: Single blinding process.

Study duration: study will be commenced after ethical committee approval.

       Method of measurement of outcome: Visual Analog Scale (VAS),

Pain levels will be measured by using the VAS scale on the day of assessment before intervention (pre-treatment) and after intervention (post-treatment).

·       Selection criteria :

 Inclusion criteria:

1.  Hemodynamically stable

 2. Above 18 years

3. Both gender will be included

4.  Concious and oriented

5.  First CABG surgery

 6. Having chest tube more then 24 hours

Exclusion criteria:

1. Patient with cognitive deficit

2. Central or peripheral neurological sequelae

3.With painful symptoms of undiagnosed cause

4. Presence of metallic implants

5. Patient with Pacemaker

6. Patient  with local infection

7. Any other musculoskeletal pain in thoracic region

8.  Burns or any other skin disease

9. Patient with invasive Ventilator  support

METHODOLOGY

1. The subjects who fulfill the inclusion criteria and are willing to participate in the study will be assigned   to one of two groups after obtaining written informed consent.

2. We will be recruiting the subjects according to eligibility criteria and are willing to participate in the study.

3. This study would be registered in CTRI.

4. Techniques applied in the study will be of standard of care.

5. We will be randomizing the subject by simple random sampling using computer generated tables the subjects will be allocated into 2 groups.

 Group A:

This group will follow the standard care of following exercise:

1. Deep breathing exercises

2.  Chest expansion exercise

3.  Incentive spirometry

4. ROM exercises for all the joints

5. Ankle toe pump exercise

This group will have Transcutaneous Electrical Nerve Stimulation (TENS) along with conventional physiotherapy treatment.

TENS from 30 min before chest tube removal and continue up to 30 min after chest tube removal. Two electrodes will place one on each side of the chest tube site over the area of anticipate maximum pain by the investigator .

TENS-Parameters:

Type – High TENS

Pulse duration - 50–60 µs

Frequency - 50 to 150 Hz.

Intensity - 5 to 15 mA or till a tingling sensation is felt.

       Group B:

This group will follow the standared care of following exercise:

1. Deep breathing exercises

2. Chest expansion exercise

3.  Incentive spirometry

4. ROM exercise to all the joints

·       Ankle toe pump exercise

1.   The breathing exercises include slow and deep inhaling air through the nose. Patients will be also ask to put their hands on the abdomen, hold their breath for about 3 s, and then exhaling slowly through semi-closed pursed lips for at least 2 to 3 s, three times as long as inhalation.

2.    Patients in this group initiate the technique 5 min before removing the chest tube.   Then the patients will ask either to close their eyes or focus on an object inside the room. The patients will be also instruct to focus on their breathing and relax simultaneously.

3.    While the patients continue with the relaxation technique, both the chest tube dressing and sutures will be remove. Then the patient will be instruct to hold their breath during CTR. The participants were instructed to repeatedly carry out the breathing exercise for 15 min. 

STATISTICAL METHODS:

·       Data will be analyzed using R software.

·       Baseline patient characteristics will be described using mean and SD for continuous variables; and frequency and percentage for categorical variables.

·       The level of Pain during and after CTR in group A and group B will be assessed using a Paired T-test if the data is normally distributed or a Wilcoxon signed rank test if the data is non-normally distributed.

·       The reduction of pain in Post assessment after CTR between the group A and group B will be assessed using Independent T test or the Mann-Whitney test based on the Normality of the Data.

·       P value less than 0.05 will be considered statistically significant

 ETHICAL CONSIDERATION

 Ethical clearance will be obtained before the commencement of the study from the institutional ethics committee. Informed consent will be obtained from the patients before the onset of the study. There are no additional investigations required for my study. Privacy and confidentiality of the patients will be maintained. Management of these patients will be along the standard guideline. The study involves using adhesive tape and gel, and for treatment, so some discomfort will happen by the tape to the patient. Apart from discomfort, no other risks and side effects have been anticipated with tasks. The Transcutaneous Electrical Nerve Stimulation has been shown to be effective in reducing pain during intercostals drainage tube remove. There is also evidence that for reducing pain which can minimize the need for analgesics and their associated adverse effects. So, based on the literature, patient may experience reduce pain.