Rajiv Gandhi University of Health Sciences s192

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 Mrs. AROKIAMMAL.S

AND ADDRESS 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 M.Sc. Nursing,

SUBJECT 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

J.P Benigni conducted study related to compression hosiery for superficial venous insufficiency Types and number of participants 72 patients from a waiting list for venous surgery.

Types of intervention (e.g. bandage A versus stocking B) Sigvaris 503 .30–40 mm Hg at the ankle

Follow up visits for four weeks The of outcome measures Visual analogue scales for: Pain,

Heaviness, Itch, SwellingNight cramps,Cosmetic.

Conclusion: No statistically significant differences following any of the four treatments. Drug + stocking better than either treatment on its own31

A study was conducted to determine, in subjects with varicose veins, the characteristics of venous disease and other factors associated with an increased risk of ulceration. 120 subjects with varicose veins and an open or healed venous leg ulcers were compared with 120 controls with varicose veins and no history of venous ulcer on this case control study. Subjects were recruited from hospital settings and primary care. An increased risk of ulceration was associated with the severity of clinical venous disease, especially with the presence of skin changes (P < .0001).

Ulceration was associated with reduced volume of blood displaced as reflected by photoplethysmography and a limited range of ankle movement(both P < .05).14

A study was conducted to assess the early efficacy and complications of ultrasound-guided foam sclerotherapy (UGFS) in a cohort of patients with varicose veins. Of 192 consecutive patients referred with varicose veins over 15 months, underwent UGFS treatment. Under ultrasound control via butterfly or Seldinger cannulation, 1 percent foam was injected into superficial veins and 3 percent foam into saphenous trunks, up to a total volume of 14 ml. In 163 legs, complete occlusion occurred after one intervention, a further 32 after a second, and one after a third (overall 91 per cent). All 23 legs with small saphenous veins had complete occlusion after one intervention compared with 64 of 97 legs with GSV incompetence (p<0.010). Occlusion rates were also higher when the GSV was cannulated directly: 56 of 70 versus 8 of 27 (p< 0.001).15

A study was conducted to evaluate the effectiveness of compression stockings the prevention of oxidative stress at work. Venous pressure of the lower limbs were measured in 55 theatre nurses who stood in the operating theatre for >6 h, 65 outpatient department nurses.

Subjects and controls were examined on two consecutive days before and after work and with and without compression stockings. Without compression stockings, lower limb venous pressure increased significantly after work in all subjects and controls (P < 0.001), while only operating theatre nurses showed significantly higher mean levels of reactive oxygen species (P < 0.001).16

A study was conducted to estimate the prevalence of lower limb chronic venous disease

(CVD) in the UK Asian male population. 100 unselected Asian men attending a local Mosque were assessed for the evidence of lower limb CVD, involving the collection of data on history and clinical signs and objective assessments of venous pathophysiology using lower limb venous ultrasonography and venous photoplethysmography (PPG). On clinical examination, 80 limbs (in

50 subjects) had clinical evidence of CVD, the majority of cases consisting of varicose veins

(CEAP C2).17 A study was conducted to assess the risk of hospitalization due to varicose vein in the lower extremities prospectively in workers standing or walking at least 75% of their time at work.

A random sample of 9653 working age adults was drawn from the central population register of

Denmark in 1991. 8664 accepted to be interviewed by telephone (response rate 90%).

Respondents (2939 men and 2708 women) were 20-59 years old and employed in 1990. During 12 years of follow up, 40 hospitalizations due to varicose vein were observed among the men and 71 among women. For employees with jobs that require prolonged standing or walking compared to all other employees, the relative risk was 1.75(95% CI 0.92 to 3.34) for men and 1.82 (95% CI

1.12 to 2.95) for women.18

A study was conducted on prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs. Random samples of 2000 subjects per location were interviewed by telephone, and a sub-sample of subjects completed medical interviews and underwent physical examination, and the presence of varicose veins, was recorded. Varicose veins were found in

50.5% of women versus 30.1% of men (P < .001).19

A study was conducted to prove the hypothesis that the development of CVD might be triggered by exogenous, occupational risk factors. We determined the prevalence and social relationship of CVD in a wide cross-section of hospital employees (n=209; medical doctors and nurses) without predocumented CVD. Prevalence, known endogenous risk factors for CVD and occupational and environmental risk factor (long periods of standing during work) were investigated. The restriction in quality of life due to symptoms of CVD was also evaluated. CVD was present in a total of 70 employees (34%), predominantly in women. Standing at work was a predisposing factor. The study demonstrated that within a representative cross-section of hospital employees in a University hospital the prevalence of CVD was highest in women, especially in those working in a standing position.20 A study was conducted to determine the inter-relationships between a range of lifestyle factors and risk of varicose veins. An age-stratified random sample of 1566 subjects (699 men and

867 women) aged 18 to 64 years was selected from 12 general practices throughout Edinburgh. A detailed self-administered questionnaire was completed, and a comprehensive physical examination determined the presence and severity of varicose veins. In both sexes, increasing height showed a significant relationship with varicose veins (male OR 1.50, 95% CI 1.18–1.93 and female OR 1.26, 95% CI 1.01–1.58). Among women, body mass index was associated with an increased risk of varicose veins (OR 1.26, 95% CI 1.02–1.54).21 6.4 STATEMENT OF PROBLEM

“ A STUDY TO ASSESS THE EFFECTIVENESS OF ELASTIC COMPRESSION

STOCKINGS IN REDUCING PAIN IN VARICOSE VEIN PATIENTS IN SELECTED

HOSPITALS AT MANDYA DISTRICT ”

6.5 OBJECTIVES

1. To compare the pain before and after elastic compression stockings in experimental group

2. To compare the pre and post pain level in experimental group

3. To test the association between the mean difference in pain in relation to socio demographic variables like age, sex, religion, family income, type of the family ,duration of hospitalization ,occupation in experimental.

6.6 OPERATIONAL DEFINITION

 Effectiveness: It refers to determine the effectiveness of elastic compression stocking and

pain reduction in varicose vein.

 Elastic compression stocking : It’s a bandage used in the Varicose vein patient to reduce

pain in the study

 Varicose vein: In this study, varicose vein refers to the veins that have become enlarged,

engorged and tortuous.

 Pain: Its the unpleasant sensation faced by the patient and measured by visual analogue

scale in the study. 6.7 ASSUMPTION

The study assume that

 The elastic compression stockings is easy to use

 The use of stockings is comfort and cheap

6.8 REASERCH HYPOTHESIS

H1: There will be the significant difference between the pre test pain level and post test

pain level of varicose vein in experimental group

H2: There will be significant association between the post test pain level and socio

demographic variables .

6.9 LIMITATOIN

The study is limited to

. The patient admitted in hospitals in Mandya.

. Both male and female patients are included

7. MATERIALS AND METHODS

7.1. RESEARCH APPROACH

The research approach for this study is experimental approach.

7.1.1. SOURCES OF DATA

Patient who have admitted in selected hospitals in Mandya.

7.1.2. RESEARCH DESIGN The research design adopted for the study is experimental with manipulation control and randomization .

7.1.3. SETTING OF THE STUDY

The study will be conducted in selected hospitals at Mandya.

7.1.4. POPULATION

Target population: all the varicose vein patient who have admitted in hospitals at Mandya

District.

7.1.5 SAMPLES

Those who are filling the sample criteria .

7.1.6 SAMPLE SIZE

The sample size will be 25 patients with varicose vein.

7.1.7 SAMPLING TECHNIQUE

Convenient sampling

7.2 METHODS OF DATA COLLECTION

The methods of data collection are by the structured interview schedule from patients with varicose vein admitted in hospitals at Mandya district.

7.3 SAMPLING CRITERIA

7.3.1 INCLUSION CRITERIA

1. Patients above 25 yrs old.

2. The patient those who are willing to participate in the study. 3. The patient those who know kannada and English or both.

7.3.2 EXCLUSION CRITERIA

1. The patient who is admitted in ICU .

2. The patient who are unconscious .

7.4 TOOLS FOR DATA COLLECTION

The tool which is used for the data collection is structured questionnaire.

7.5 DATA COLLECTION PROCEDURE

Data collection is proceeded after getting the permission from concerned authorities. Data will be collected by structured questionnaire.

7.6 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO

BE CONDUCTED ON PATIENTS OR OTHER ANIMALs?

7.7 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION

IN CASE ABOVE?

Yes 7.8. LIST OFREFERENCE:

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