Efficacy of Nursing Skin Care Protocol on Prevention of Skin Related Problems among Newly Diagnosed Diabetic Patients

Background:Approximately 400 million people would be afflicted with diabetes by 2025, projected worldwide.In India, about 50.9 million people suffer from diabetes, and this figure willgo up to 80 million by 2025. Diabetes leads to blindness, kidney failure, heart attacks, stroke and foot ulcer. Skin problems are increasing in diabetic patients. It is estimated that 30% of diabetes patients will experience a skin problem at some stage throughout the course of their disease. Many skin care guidelines are given for diabetic foot care, but nursing skin care protocolfor diabetic patients is not available. Less attention is given to complete skin care in diabetes routine care.There is need to develop Nursing skin care protocols for prevention of skin problems in diabetes. Objectives:To validate the developed nursing skin care protocol on prevention of skin related problems among newly diagnosed diabetic patients, to assess the skin problems in experimental group and control group, and to assess the efficacy of nursing skin care protocolin experimental group and routine skin care with coconut oil in control group. Study Protocol David et al.; JPRI, 33(31A): 1-8, 2021; Article no.JPRI.68563 2 Methodology: Study design is randomized controlled trial.Study will be carried out in hospital setting with 140 participants. Random allocation and concealment with single blinding will be done.Intervention is Nursing skin care protocolconsist of Daily skin inspection, Bathing, Drying, clothing, Application of lotion, Hydration, Injury prevention, Nail careandHair care, Sugar control, Dermatological consultation and Physician consultation. Semi structure questionnaire, skin assessment tool[ GI, Glammal score for xerosis,Visual Analogue Scale for pruritus, Questionnaire on erythema,hair and nail colourchanges] and self-reported practice checklist will be used to collect data. Expected Results: Investigator expects newly diagnosed diabetic patients will not develop any skin related problems after using Nursing skin care protocol. Conclusion: Diabetic patients will be able to utilized developed nursing skin care protocol routinely to prevent skin related problems.


INTRODUCTION
Diabetesis a metabolic disease that raisesblood sugar level. The hormone insulin moves sugar from the blood into the cells to be stored or used for energy. With diabetes, our body either doesn't produceenough insulin or can't effectively usethe insulin it does make [1].
Diabetes is one of the most prevalent disease in the world. By 2025 nearly 400 million people would be affected by it. In India, nearly 50.9 million people suffer from diabetes, and this numberis likely to go up to 80 million by 2025, making Indian the 'Diabetes Capital' of the world. Delhi alone has an estimated 29.8 lakh people suffering from this disease [2].

Background and Need
The worldwide prevalence of diabetes among adults over 18 years of age has increasedfrom 4.7% in 1980 to 8.5% in 2014. Diabetes prevalence is rapidlyrising in middle-and lowincome countries. In 2016 diabetes was the seventh leading cause of death, as per WHO. Regular physical activity, healthy diet,maintaining weight and avoiding tobacco use are the ways to prevent or delay the onset of type 2 diabetes [3].
Skin problems are one of the most common problem among diabetic patients.30% of patients with diabetes mellitus will experience a skin problem at some stage throughout the course of their disease. Candida and impetigo are more commonskin conditions in diabetic patients [4].
A study revealed that, Cutaneous infections were noted in 148 (37%) diabetics of which fungal infections were the most common seen in 106 (26.5%) patients, followed by xerosis in 121 (30.25%) and acrochordons in 71 (17.75%) patients. Cutaneous changes associated with neurovascular complications included diabetic foot in 3%, diabetic dermopathy in 2%, and pigmented purpuric dermatosis in 0.25% of the diabetics.Study revealed that A joint effort between dermatology and general medicine is necessary for the early recognition and treatment of the skin conditions and also to ensure adequate sugar control [5].
Diabetesis associated with a broad range of dermatologic conditions. Many of skin problems are present in diabetic patients.  [7].
Evidence promisethat daily applications of a moisturizing formulation on the body, particularly on compromised lower extremities, often control both pruritus and xerosis [9].
Skin problems are increasing in diabetes. Diabetic patients are prone to develop skin problems. These problems are dueto increased sugar level, as well as due to complications of diabetes like chronic kidney disease, neuropathy, decreased circulationand sometime the side effects of medicine also may lead to, xerosis, pruritus, erythema and other skin problems.
Many studies are carried out on diabetic foot ulcers and its management. Above Review suggested that use of emollients, skin hygiene, skin examination and dermatological consultation is needed for proper skin care in diabetes skin conditions to prevent many of the skin disorders in diabetes.Many skin care guidelines are given for diabetic foot care, but nursing care protocols for diabetic patients are not available for prevention of skin related problems in diabeticpatients. Less attention is given to complete skin care in diabetes routine care. Thus, the investigator felt that there is need to develop Nursing Skin Care Protocols for prevention of skin problems in diabetic patients.

Intervention for Experimental Group
Nursing Skin Care Protocol will be made by investigator, depending on the evidenced based guideline for skin care. It will include, skin inspection,cleaning of skin [Bathing], drying, clothing,application oflotion, hydration, prevention of injury, care of nail and hair, sugar control, dermatological consultation, physicians consultation. It will be provided for the eachnewly diagnosed diabetic patients under study in experimental group.Instructions for the skin care will be given according to protocol.

Control Group
Newly diagnosed diabetic patients of control group will receive routine skin care with instruction of only coconut oil application on skin as lotion.Participant will be instructed to informed to the investigator before they make any changes.

Procedures for Monitoring Adherence
Follow up will be done on phone and physical examination will be carried out by investigator in 3 observation. A checklist will be given to the participantfor daily marking and it will be produce on follow up day to investigator for record.Participant are allowed to visit the physician and dermatologist if they develop any skin problems during the trial and they also will be instructed to inform to investigator.

Outcomes
Primary outcome: Development of Nursing Skin Care Protocol for newly diagnosed diabetic patients and prevention of skin related problems. Secondary outcome: Early detection of skin related problems among newly diagnosed diabetic patients and prompt action. Recruitment: Subjects will be identified through existing patients of selectedHospital andthrough physician referrals. Investigator, will select the experimental and control group. Allocation: Lottery method will be used to allocate the participant in to experimental and control group. Allocation concealment mechanism: Sequentially numbered opaque sealed envelopeswill be used to by investigator to allocate the subjects and to enrol the participant and also toassign participant to treatment. Blinding (masking): Trial participant will be blinded after assignment to treatment. Data Collection Methods: Official permission will be taken from authority to conduct study.Investigator will introduce herself with purpose of study to samples.Selection of sample will be as per inclusion criteria.Participant's informed consent will be taken before starting study. Sample will be allocated to experimental and control group. First all newly diagnosed diabetic patients under study will be assessed.Intervention will be given to experimental group and control group will receive routine skin care. Observationwill be in 3 observations. Pilot Study: Pilot study will be carried out.Necessary changes on the basis of observations of pilot studywill be implemented in the protocol before final study.

Tool and Techniques
1. Semi structured questionnaire for demographic data 2. Skin assessment tool, [GI, Glammal score for xerosis,Visual Analogue Scale for pruritus, Questionnaire on erythema,hair and nail colourchanges] 3. Self-reported practice checklist.
Validity: Content and construct validity of the tool and protocol will be done by subject experts. Reliability: Split half method and interrater reliability Data Management: Data collected will be prepared in master sheet with proper coding and it will be stored by investigator. Confidentiality of data will be maintained. Statistical Methods: Descriptive analysis will be like frequency, percentage,mean and standard deviation.To determine effectiveness of Nursing skin care protocol t test will be utilized. Comparison between experimental and controlgroup will be done bychi-square test or Fischer exact test whicheverwill be applicable.All analysis will be performed using SPSS software.

Monitoring of Data:
Investigator will herselfconduct the monitoring of data. Auditing: Auditing of trial data will be carried outby investigator. Protocol Amendments: Any changes in protocol will be informed to institutional ethical committeeand clinical trial registry of India every six monthly. Confidentiality: Code number will be assigned to enrolled participant to maintain confidentiality. Declaration of Interests: No conflict of interest. Access to Data: Investigatorand statistician will have reachto the data.
Post trial observation will be carried out for 6 months to all participant and will participant will be referred to physician and dermatologist if needed.

RESULTS
Investigator expectsnursing skin care protocol will prevent the skin related problemslike Redness, Dry skin, Itching, Wheal, Skin colour changes, Nail problem and Hair problem in newly diabetic patients. During trial if any of the study participant develop the skin disorder it will be identified early and prompt treatment will be initiated and number of times skin problems developed, types of problems, number of visits to consultant, duration of treatment, severity of problems will be compared in both groups [10].

DISCUSSION
Aresearch was conductedto ruled outthe effect of an emollient ondiabeticpatients.Fortypatients with diabetes applied the emollient two times a dayfor a month on one arm and one leg, in normal conditions. A 1-month treatment with an emollient allows a similar skin hydration rate in diabetics to that in healthy people. Dry skin improvement was found witha significant reduction in pruritus and desquamation, and a significant improvement in the skin barrier function.Skin complicationscan be limited by use of emollient treatment in diabetes [10]. This study is suggestive of use of emollient to treat and prevent skin condition which is expected by investigator in current study.
A study with 100 diabeticpatientswithskin lesions, xerosis was foundin 44% of the patients.Patients with kidney disease also frequently suffer from xerosis. The study suggested that consultation to a dermatologist is necessary for xerosis.Health care provider should educate patients about the importance of skin hygiene, with applying fragrance-free creams or lotions within 3 minutes of bathing to trap moisture within the skin. [11]. Study revealed that skin hygiene use of lotions are beneficial in dry skin care. In current study also investigator is including in protocol skin hygiene and use of lotion [11].

CONCLUSION
Nursing skin care protocol for newly diagnosed diabetic patients developed by investigator will beutilized by diabetic patientsroutinely to prevent skin related problems. Study will help to early detect skin related problems in diabetic patients and prompt action will be initiated.

CONSENT
Investigator will obtain informed consentwith the help of consent form in participant own language.

ETHICAL APPROVAL
The study has been granted ethical approval by institutional ethics committee, Datta Meghe Institute of Medical Sciences (Deemed to by university)Sawangi (Meghe) Wardha. The investigator will be disseminate the study result and implication of the study via publication.