Acu Tens Versus Low Level Laser After Open Heart Surgeries

NCT06637085 | Completed

• 1 other identifier: p.T.REC/012/003894
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Arrhythmia

Outcome Measures

Primary Outcomes (1)

• heartrate variability.

  SDANN Standard deviation of the averages of RR intervals in all 50minute segments of a 24-hour recording.rMSSD Square root of the mean of the squares of differences between adjacent RR intervals

  heart rate variability parameters recorded for 24 hours 1st day post operative and at the last day before discharge from hospital for each group. before discharge from hospital .

Secondary Outcomes (1)

• Atrial fibrillation

  AF recorded in 24 hours 1st day post operative and at the last day before discharge from hospital for each group.

Study Arms (3)

LLLT group

EXPERIMENTAL

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

Device: LLLT; Other: traditional physical therapy

ACU tens group

EXPERIMENTAL

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

Other: traditional physical therapy; Device: ACU TENSE

control group

ACTIVE COMPARATOR

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)

Other: traditional physical therapy

Interventions

LLLT 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 .

LLLT group

traditional physical therapy OTHER

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

ACU tens group; LLLT group; control group

ACU TENSE DEVICE

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

ACU tens group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Ainy Hospital

Cairo, Egypt

Location

Related Publications (3)

• Chandler HK, Kirsch R. Management of the Low Cardiac Output Syndrome Following Surgery for Congenital Heart Disease. Curr Cardiol Rev. 2016;12(2):107-11. doi: 10.2174/1573403x12666151119164647.

  PMID: 26585039 BACKGROUND

• Demirel S, Akkaya V, Oflaz H, Tukek T, Erk O. Heart rate variability after coronary artery bypass graft surgery: a prospective 3-year follow-up study. Ann Noninvasive Electrocardiol. 2002 Jul;7(3):247-50. doi: 10.1111/j.1542-474x.2002.tb00171.x.

  PMID: 12167187 BACKGROUND

• Syuu Y, Matsubara H, Hosogi S, Suga H. Pressor effect of electroacupuncture on hemorrhagic hypotension. Am J Physiol Regul Integr Comp Physiol. 2003 Dec;285(6):R1446-52. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.

  PMID: 12893654 BACKGROUND

Related Links

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MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• zeinab helmy, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstanr lecture at faculty of physical therapy

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: October 15, 2024
• Study Start: January 12, 2023
• Primary Completion: November 5, 2023
• Study Completion: February 3, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)