Acu Tens Versus Low Level Laser After Open Heart Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-02-03

Brief Summary

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Increase in heart rate (HR) is a normal sympathetic response to body trauma and a common consequence of major surgical procedures,A high resting HR is associated with increased myocardial work that may be detrimental to patients with a marginal myocardial oxygen supply,the aim of this study is To compare between the effects of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery.

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Detailed Description

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Autonomic function reached lowest values 3-6 days after coronary artery by pass graft (CABG) and could take up to 60 days to return to pre-surgery values (pedro et al., 2005).

Alterations in pulse may provide a first indication that a patient is developing hemodynamic instability. While many factors may influence the pulse rate, including fever, exercise, medications, and thyroid hormone status, a high pulse rate is often a sign of high levels of endogenous catecholamines, blood loss or dehydration (Jonathan ,2009.) Hemodynamically unstable patients don't have enough pressure in the circulatory system to keep blood flowing reliably to all the various parts of the body where it needs to be at the same time.

Vagus nerve stimulation (VNS) can increase HRV and reduce sympathetic nerve outflow, which is desirable in conditions characterized by enhanced sympathetic nerve activity .

Application of Acu-TENS over acu-point PC6 facilitated a faster return of resting HR to preoperative levels, maintained BP during the acute postoperative period and enhanced a quicker return of rate pressure product (RPP), in patients after acute cardiac surgery .

Faster return of the raised resting HR to preoperative levels in Acu-TENS application was possibly due to induced vagal stimulation and/or inhibition of sympathetic neural activity through the acu-points PC6 .

Low level laser therapy (LLLT) is a non-invasive and safe method, to recover parasympathetic/sympathetic nervous system balance .

this study show the differences between the effect of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery

Conditions

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Heart Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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LLLT group

The LLLT group consist of (20) patients, who will receive the vagus nerve stimulation through LLLT from the first day postoperative until the seventh day, in addition to routine physiotherapy program

Group Type EXPERIMENTAL

LLLT

Intervention Type DEVICE

low level laser therapy Probe laser device: (Laserklasse2M, EN60825-1, +A2:2002, W.L= 635-670nm, P\<6mW, German):low level laser therapy It will be used to stimulate vagus nerve .

traditional physical therapy

Intervention Type OTHER

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

ACU tens group

The acu tense group consist of (20) patients, who will receive the acu tens on (pc6) point from the first day postoperative until the seventh day, in addition to routine physiotherapy program

Group Type EXPERIMENTAL

traditional physical therapy

Intervention Type OTHER

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

ACU TENSE

Intervention Type DEVICE

Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .

control group

The control group consist of (20) patients, who will receive only routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

Group Type ACTIVE_COMPARATOR

traditional physical therapy

Intervention Type OTHER

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

Interventions

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LLLT

low level laser therapy Probe laser device: (Laserklasse2M, EN60825-1, +A2:2002, W.L= 635-670nm, P\<6mW, German):low level laser therapy It will be used to stimulate vagus nerve .

Intervention Type DEVICE

traditional physical therapy

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

Intervention Type OTHER

ACU TENSE

Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1- 60 patients from both sexes . 2- undergo cardiac surgery through a median sternotomy. 3- age will be ranged from 45-65 years old. 4-Body mass index from 25 to 29.9 kg/m25-

Exclusion Criteria

* 1- Previous thoracic surgery. 2- Emergency or urgent cardiac surgery. 3- hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg. 4- Renal insufficiency with serum creatinine ≤1.8 mg/dl after surgery. 5- Other medical conditions such as uncontrolled diabetes, and hypertension . 6- Patients who are unable to follow verbal instructions.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No