RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE- KARNATAKA

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

AROKIAMMAL.S

M.Sc. NURSING, I YEAR,

MEDICAL SURGICAL NURSING

YEAR 2012-2014.

NEW NAVODYA INSTITUTE OF NURSING,

MANDYA.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Mrs. AROKIAMMAL.S
I year M.sc. Nursing,
NAVODYA INSTITUTE OF NURSING,
MANDYA.
2. / NAME OF THE INSTITUTION / NAVODYA INSTITUTE OF NURSING,
MANDYA.
3. / COURSE OF THE STUDY AND SUBJECT / M.Sc. Nursing,
Medical surgical Nursing
4. / DATE OF ADMISSION OF THE COURSE / 25/08/2012
5. / TITLE OF THE STUDY / “A Study To Assess The Effectiveness Of Elastic Compression Stockings In Reducing Pain In Varicose Vein Patient In Selected Hospitals At Mandya District”

PROFORMA FOR REGISTREATION OF SUBJECT FOR DISSERATION.

DISSERTATION PROPOSAL

“A STUDY TO ASSESS THE EFFECTIVENESS OF ELASTIC COMPRESSION STOCKINGS IN REDUCING PAIN IN VARICOSE VEIN PATIENT IN SELECTED HOSPITALS AT MANDYA ”

SUBMITTED BY

Mrs. AROKIAMMAL.S

I YEAR M.sc. NURSING

NAVODYA INSTITUTE OF NURSING,

MANDYA.

(2012-2014)

6. BRIEF RESUME OF INTENDED STUDY

6.1 INTRODUCTION

Varicose veins are veins that have become enlarged and tortuous. The term commonly refers to the veins on the leg, although varicose veins can occur elsewhere. Veins have leaflet valves to prevent blood from flowing backward. Leg muscles pump the veins to return blood to the heart, against the effects of gravity. When veins become varicose, the leaflets of the valves no longer meet properly, and the valves do not work. This allows blood to flow backwards and they enlarge even more.1

Varicose veins are most common in the superficial veins of the legs, which are subjected to high pressure when standing. Besides cosmetic problems, varicose veins are often painful, especially when standing or walking. They often itch, and scratching them can cause ulcers. Serious complications are rare. Non-surgical treatments include Sclerotherapy, Elastic Stockings, Elevating the legs and Exercise. The traditional surgical treatment has been vein stripping to remove the affected veins. Newer, less invasive treatments, such as ultrasound-guided foam sclerotherapy, radiofrequency ablation and endovenous laser treatment are slowly replacing traditional surgical treatments. Because most of the blood in the legs is returned by the deep veins, the superficial veins, which return only about 10 per cent of the total blood of the legs, can usually be removed or ablated without serious harm. Varicose veins are distinguished from reticular veins and telangiectasias, which also involve valvular insufficiency, by the size and location of the veins.1

Elastic stockings have been used to treat varicose veins and their complications for over 150 years.1 Recent workers have emphasized that elastic stockings need to exert a graduated compression on the leg to encourage the centripetal flow of blood. Thromboembolic- deterrent stockings have recently been shown to be effective in reducing the incidence of postoperative deep venous thrombosis.

Methods of measuring the compression of elastic stockings on a limb have been based on the insertion of a pressure sensor, in the form of a fluid- or air-filled balloon, between the stocking and the limb. This balloon is connected to a manometer which records the pressure exerted by the stocking.

Venous edema is one of the most important indications for compression therapy, edema causes impairment of cutaneous circulation, which results in reduction of nutritive capillaries and lack of supply with oxygen and nutritiens. Patients complain about heavy legs, tension and pain of lower limbs. Compression by means of bandages and compression stockings reduce the increased volume of lower limbs, thereby improving quality of life.

Compression therapy (bandage, stockings and sleeves) have some documented positive actions on lymph edema: a) reduction of limb volume, through several mechanisms: increase of interstitial (transmural) pressure, increase of protein and fluid recovery in the lymphatic network, increase of lymphangion contractility, shift of fluids from affected to non (or hypo-)affected proximal areas of the limb,

b) improvement of musculo-vascular foot/ calf pump,

c) protection of the skin ( prone for infections etc.)32

6.2 NEED FOR THE STUDY

Varicose veins are a very common condition. Women tend to be more affected than men, with approximately 30% of women developing varicose veins in their lifetime, compared to 15% of men.3 15 to 20 % of population in India is suffering from varicose vein.

Primary varicose veins are a typical manifestation of chronic venous insufficiency.

The etiology of varicose veins is still incompletely understood despite the fact that it

is a very common disease affecting all ages from teenagers to elderly people.

The prevalence of varicose veins varies substantially in different parts of the world, being highest in the western world; mostly from 10% to 30% in men and from 25% to 55% in women in population-based studies (Callam 1994, Beebe-Dimmer et al. 2005,Robertson et al. 2008).

In population in middle to late adulthood (40–69 years) the incidence of varicose veins ranged from 9 to 19 per 1,000 person-years in men and from 19 to 26 per 1,000 person-years in women in follow-up studies from Finland andthe USA (Brand et al. 1988, Mäkivaara et al. 2004).

The prevalence of varicose veins increases with age (Cesarone et al. 2002, Crique et al. 2003, Kroeger et al. 2004). Hence every way to prevent the disease in this aging world population is worthwhile. Other reported risk factors are female gender (Brand et al. 1988, Sisto et al. 1995, Crique et al. 2003, Carpentier et al. 2004), parity (Sisto et al. 1995, Criqui et al. 2007), positive family history of varicose veins (Cornu-Thenard et al. 1994, Scott et al. 1995, Lee et al. 2003) and obesity in women (Brand et al. 1988, Lee et al. 2003). There are also many hypothetical postulated risk factors such as diet and other lifestyle factors, occupation involving prolonged sitting or standing, and hormone medications, but the existing data is inconsistent for further conclusions. At the moment, it is assumed that the etiology of varicose veins is multifactorial, but the more specific role of both environmental and genetic factors in the development of varicose veins is not known (Ng et al. 2005, White and Ryjewski 2005, Raffetto and Khalil 2008). An understanding of the basis of varicose veins formation will provide possible tools for prevention or highlight new tools for treatment.

The knowledge of the risk indicators of varicose veins is mainly based on cross-sectional surveys conducted in a selected population (e.g. hospital or clinic patients or occupational groups of only one sex). The temporal relationship between the potential risk factor (cause) and the outcome (effect) is very important in estimating causality. In cross-sectional studies, the estimation of cause and effect is simultaneous and it is often unclear whether the hypothetical cause preceded the effect in time or the opposite. Follow-up studies do not have these problems because the incident cases of the disease are detected in subjects originally free of it and the data on the risk factorsis collected at entry of the follow-up.35

Recent studies suggest that prolonged standing is associated with development of varicose vein. Standing in one place for a long time increase venous pressure in the legs and feet and weakens the blood vessel wall. Occupations that require prolonged standing (eg: Teachers, O T Nurses) also results increase venous pressure.5

Varicose veins are a major vascular disease that affects more than 25 million adults in the United States.7 Because of high prevalence, varicose vein of the legs cause considerable morbidity and loss of labour.8

It is estimated that 41% of all women will suffer from abnormal leg veins by the time they are in the 50s.9 In a recent study, we observed that Operating Theatre Nurses, without any sign of CVI, who stand for >90% of their working time, show high levels of venous pressure of the lower limbs.10

A large Danish population study found that prolonged standing or walking at work was an independent predictor of the need for varicose vein treatment 11

A survey of varicose veins in a rural area of northern New Guinea showed a very low prevalence in women (0.1 per cent in females aged 20 and over) and a modest prevalence in men (5.1 per cent in the same age range).12

One large US cohort study found the biannual incidence of varicose veins was 3% in women and 2% in men. The prevalence of varicose veins in Western populations was estimated about 25–30% in women and 10–20% in men. A recent Scottish cohort study has found a higher prevalence of varicose of the Saphenous trunks and their main branches in men than in women (40% men v 32% women). Other epidemiological studies have shown prevalence rates ranging from 1% to 40% in men, and 1% to 73% in women.13

A study conducted by Edwards et. al (2005) on “Improved Healing Rates For Chronic Leg Ulcers Pilot Study Results From A Randomized Controlled Trial A Community Nursing Intervention” reveals that venous leg ulcers are frequent source of chronic ill health and a considerable cost to health care system. This paper reports the effectiveness of a community based ‘Leg Club’ environment in improving healing rates of venous leg ulcers. Results suggest that a community based “Leg club” environment provides benefit additional to wound care expertise and evidence based care. Knowledge gained from the study provides evidence to guide service delivery and improve client outcome.2

6.3 REVIEW OF LITERATURE.

The study conducted in Switzerland To determine the efficacy of compression stockings in preventing emergent varicose veins in pregnancy.: A prospective randomized controlled study in the outpatient department including women with uncomplicated pregnancies <12weeks at outset of study. A no-stockings control group (n = 15) was compared with two treatment groups: group 1 (n = 12) wore compression class I stockings (18–21 mm Hg) on the left leg and class II stockings (25–32 mm Hg) on the right; in group 2 (n = 15), the compression classes were reversed. Stockings were worn from study entry to term. Endpoints were emergence and worsening of superficial varicose veins, long saphenous vein reflux at the sapheno-femoral junction, and leg symptoms (pain, discomfort, cramps) during pregnancy. Results: Both classes of compression stockings failed to prevent the emergence of superficial varicose veins. However, long saphenous vein reflux at the sapheno-femoral junction was observed in the third trimester in only 1/27 treated women vs. 4/15 controls (p = 0.047); in addition, more treated women reported improved leg symptoms (7/27 vs. 0/15 controls; p = 0.045). Conclusions: Although compression stockings do not prevent the emergence of gestational varicose veins, they significantly decrease the incidence of long saphenous vein reflux at the sapheno-femoral junction and improve leg symptoms. Our results also suggest that superficial varices and deep venous insufficiency may have a different aetiology.33

J. Caprini conducted a study on elastic compression stockings for prevention of deep vein thrombosis. Types and number of participants 9 randomised control studies (rcts) GCS alone: placebo 581; GCS group 624 7 rcts GCS Plus another method: placebo 505; treatment 501 (GCS = Graduated compression stocking). THERE WAS A Randomization Types of intervention (e.g. Bandage A versus stocking B. a) stockings (GCS)vs Placebo b) stockings (GCS) + other method vs Placebo Types of outcome measures DVT (I 125 fibrinogen) a) Placebo 154/581 (27%) DVT GCS 81/624 (13%) DVT OR 0,34 b) Placebo 74/505 (15%) GCS +other method 10/501 (2%) OR 0,24 The author concluded Compression stockings are effective in diminishing the risk of DVT in hospitalized patients. On a background of another method of prophylaxis they are even more effective than GCS alone26

The study by Moffatt CJ, McCullagh L et el. Suggests comparing four layer bandage for 109 patients randomized to either four layer bandage or a single layer bandage (Sure press) applied over padding. Application technique standardized. Analysis revealed that after 24 weeks a total of 71 (56%) of ulcers had healed. The healing rate in the four layer was 47/57 (82%) and in the single layer 24/52 (46%) (p < 0.001). Withdrawal and adverse events were similar.

A multi-centre randomised trial comparing a Vari-stretch compression system with Profore. 13th Conference European Wound Management Association, Pisa, May 2003 ,300 patients recruited from 5 countries, 24 sites, standardized application methods with modification of application to the new system during the trial. Comparable the ulcer level have reduced.27

The study reported by M. Neumann CJ. Risk factors for leg ulcer recurrence: a randomized trial of two types of compression stockings. Age Agein A prospective randomised trial of class 2 and class 3 elastic compression in the prevention of venous ulceration Types and number of participants 300+166 (Harper and Franks) types of intervention (e.g. bandage A versus stocking B) Follow up visits Up to 60 month Types of outcome measures Recurrent ulcers The author Concluded No compression is associated with recurrence Recurrence rate low with Class III stockings.28

The study by M. Jünger Comparison of leg compression stocking and oral horsechestnut seed extract therapy in patients with chronic venous insufficiency,Types and number of participants 240 (194 women) with chronic venous insufficiency Types of intervention (e.g. bandage A versus stocking B) Stockings class II versus horse chestnut seed extract (50 mg Aescin twice daily) . Follow up visits 12 weeks study duration randomized to either compression, HCSE, or placebo Types of outcome measures Water displacement plethysmography . Conclusion of the authors decrease by 53.6 ml with HCSE decreased by 56,5 ml with stocking compared to placebo after 12 weeks HCSE offers an alternative to compression therapy • Flaws of the trial Treatment with oedema-preventive drugs are accepted by 67% of patients. Volume decrease in the range of 50 ml corresponds to a mean reduction in calf circumference of 2–3 mm in 12 weeks! Compression treatment improves venous hemodynamics (reduction of venous reflux, ambulatory venous hypertension and of capillary hypertension), which is not shown for drug treatment.29

The study of M. Perrin methods of limb compression following varicose veins surgery. Phlebology 1987; 2: 165–72 Summary: Prospective randomised study. Postoperative compression including crepe (13 patients), elastocrepe (10 patients) and stockings producing 30 mmHg at the ankle (11 patients). Pressures exerted by the bandages and stockings were measured during the 24 h following surgery. Initially the bandages exerted greater pressure than the stockings. However, the bandaging techniques lost 13–38% of their compression in the first hour and 29–48% in 24h compared with 3–5% for the compression stocking Conclusion: the stockings provided a more constant compression with maintained graduation compared with the bandages.Types and number of patients: Varicose veins treated by HL+ GSV trunk stripping+ tributaries stab avulsion: 34 patients. Types of intervention: Postoperative compression comparing crepe (13 patients), elastocrepe (10 patients) and stockings producing 30 mmHg at the ankle (11 patients). Follow-up visits Continuous evaluation 24 hrs after operation Types of outcomes measures Pressure measurement, From a clinical point of view the correlation between the pressure exerted and the clinical benefits has never been validated in the immediate postoperative period30