AIM: EFFECT OF MINDFUL MEDITATION ON ANXIETY, HEMODYNAMIC

PARAMETERS AND INFLAMMATORY MARKERS ON PATIENTS UNDERGOING

SURGERY FOR VARICOSE VEINS

PRIMARY OBJECTIVE:

To assess effect of mindful meditation on anxiety level using STAI (state trait anxiety

inventory) scale

SECONDARY OBJECTIVES:

To assess the effect of mindfulness meditation on intraoperative parameters (blood

pressure, heart rate, respiratory rate)

To assess the effect of mindfulness meditation on serum cortisol level, Interleukin – 6, C-

reactive protein and Random blood sugar.

Justification of the Study: Mindfulness is a type of meditation in which you focus on being

intensely aware of what you're sensing and feeling in the moment, without interpretation or

judgment. Practicing mindfulness involves breathing methods, guided imagery, and other

practices to relax the body and mind. Meditation has been studied in many clinical trials.

Preliminary research indicates that meditation can also help people with asthma and

fibromyalgia. Meditation can help you experience thoughts and emotions with greater balance

and acceptance. Meditation also has been shown to: improve attention, decrease job burnout,

improve sleep, improve diabetes control and help reduce stress. Varicose veins are a common

venous disease of the lower extremity which affects more than 30 per cent of the adult

population in Western countries. Varicose veins are elongated, dilated, and tortuous veins.

Varicose veins range in severity from the undesirable appearance of telangiectasia to large

tortuous varicosities with or without associated swelling, dermatitis, pigmentation, or cutaneous

ulcerations. Varicose veins represent one of the most frequent vascular diseases and are in most

cases benign. However, advanced disease is frequently associated with complications such as

chronic venous insufficiency (CVI) and superficial vein thrombosis. The pathogenic mechanisms

are not well understood. Besides increased venous pressure, it is suggested that local blood

constituents trigger various mechanisms responsible for the progression of the disease and its

complications. Few studies have investigated systemic inflammation in patients with varicose

veins, and reports on inflammatory markers in varicose veins are very rare. One study found a

marked expression of monocyte chemoattractant protein-1, macrophage inflammatory protein,

interferon inducible protein-10 and interleukin-8 in varicose veins. The authors suggested that

these chemokines might play an important role in the pathophysiology of varicose veins and

complications by recruiting leukocytes to the vein wall and contributing to inflammation.

Inflammatory markers, including C-reactive protein (CRP), erythrocyte sedimentation rate

(ESR), and plasma viscosity (PV) are commonly used in primary care for diagnosis and

monitoring of inflammatory conditions, including infections, autoimmune conditions, and

cancers. In varicose veins, increased levels of inflammatory markers are indicators of endothelial

damage and increased procoagulant activity. These findings support the hypothesis that the

constitution of blood in varicose veins differs from that of systemic blood. Mindfulness-Based

interventions have greatly increased in popularity in recent years. However, randomized and

adequately controlled trials are needed to validate findings and provide additional confirmation

of biological effects.

Methodology:

After taking approval from the institutional ethics committee, patient enrolment will be

done after taking informed consent.

After inclusion, the patients will be randomly divided into two groups of 30 each, i.e.,

Group A (patients to whom mindful meditation will be advised along with surgery) and

Group B (patients to whom only surgery is advised).

All Data including demographic profile symptoms and examination findings will be

recorded.

The CEAP elements classification system will be used to classify chronic lower extremity

venous disease (CVD).

Superficial veins will be evaluated in the erect posture.

Limb will be examined in a non-weight-bearing position.

Position of the limb to be examined will be kept in external rotation of the hip and a little

flexion of the knee with weight of the body on opposite limb.

Patients will be given Spinal anaesthesia for the surgery with Bupivacaine 0.5% (heavy)

according to weight (5 mg) and Fentanyl (25 mcg)

During surgery patient will be advised to do diaphragmatic breathing.

Anxiety will be measured on STAI scale in both groups at the time of the patient

counselling from the surgery, evening PAC, preoperatively on the day of surgery and

post operative lay 6 hours after surgery.

Vitals including heart rate, blood pressure, respiratory rate will be recorded in both

groups before the patient counselling from the surgery OPD during evening PAC and on

the morning of surgery, intraoperatively and post operative lay 6 hours after surgery.

Blood glucose will be measured during evening PAC, preoperatively (on the morning of

surgery) and post operatively.

Serum cortisol, CRP, RBS, IL 6 will be measured preoperatively and postoperatively on

2 nd day of surgery. All the values will be recorded and compared among both groups.

Statistical analysis:

The data will be expressed as mean and standard deviation (SD) or median, range and percentage

as appropriate. All the categorical data will be compared by using chi square test. Continuous

variables in two groups will be compared by t- test. The p-value <0.05 will be considered as

significant. The statistical analysis will be done using SPSS 22.0 version (Chicago, Inc., USA)

windows software.