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临床试验/NCT05630417
NCT05630417已完成不适用

Investigation of the Effect of Geriatric Massage Applied to the Elderly With Type 2 Diabetes on Diabetes Symptoms and Blood Parameters

Bayburt University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Diabetes Symptoms Checklist Scale

研究概览

简要总结

There is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes. 60 elderly people who type 2 diabetes who applied to the Internal Medicine Polyclinic of Bayburt State Hospital in the city center of Bayburt will the diagnosis of Type 2 diabetes will form the sample of the study. The sample will consist of two groups, the geriatric massage group and the control group. Data will be collected with the "Elderly Information Form", "Standardized Mini-Mental Test", "Diabetes Symptoms Checklist Scale", "Blood Parameters Monitoring Form". "Geriatric Massage" will be applied as an intervention. The geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage and 10 minutes back massage, two days a week for eight weeks. The control group will receive the institution's standard of care. Frequency, number, mean, Student's t test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation and Regression Analysis will be used in the analysis of the data. As a result of this study, it is anticipated that the effects of geriatric massage on diabetes symptoms and blood parameters in the elderly with Type 2 diabetes will be determined and these effects will be included in evidence-based guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

In order to keep the possibility of randomization of the elderly into groups and to minimize the possibility of their interaction with each other, the elderly who applied to Bayburt State Hospital Internal Medicine Outpatient Clinic randomly on Mondays and Wednesdays with the diagnosis of Type 2 diabetes will be included in the geriatric massage group, and the elderly who apply on Tuesday and Thursday will be included in the control group. In addition, individuals will be stratified according to age (65-74 years / 75-84 years old) while being assigned to the experimental and control groups.

入排标准

年龄范围
65 Years 至 84 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65-84
  • No visual or hearing impairment
  • Ability to communicate verbally
  • Applying to Bayburt State Hospital Internal Medicine Polyclinic
  • Having a diagnosis of Type 2 diabetes for at least six months
  • A score of 25 and above on the Standardized Mini Mental Test
  • Agreeing to participate in the research

排除标准

  • Having vascular disease (thrombus, phlebitis, arterial embolism, severe venous ulceration)
  • Having heart failure, pacemaker and neurological disease
  • Body temperature being higher than 37.5°C for more than two days, suspected or diagnosed with inflammation
  • Having acute pain
  • Cancer and undiagnosed malignancies, receiving chemotherapy and radiotherapy
  • Presence of any scar tissue, chronic inflammatory skin diseases on the back
  • Having foot amputation, fracture, infection, wound, skin disease, pathology and neuropathy related to muscles and bones

结局指标

主要结局

Diabetes Symptoms Checklist Scale

时间窗: First week

This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.

Standardized Mini Mental Test (SMMT)

时间窗: will be applied on the first day. If the Standardized Mini Mental Test result is not 25 points or more, the patient will be excluded.]

This test consists of "orientation, recording, attention, calculation, reminder, language tests and configuration" sections. Test; It is a test that can be administered by physicians, nurses and psychologists in a short time (10 minutes), outpatient conditions or at the bedside. The test was developed for the purpose of short-term cognitive assessment in the elderly, especially in the examination of delirium or dementia.Each question in the test is worth "1" point. The lowest score that can be obtained from the scale is "0" and the highest score is "30". According to the points received; 0-12 points at "severe" level, 13-22 points at "moderate" level and 23-24 points at "mild" level as "cognitive impairment"; A score between 25 and 30 is considered as "no cognitive impairment".

Elderly Information Form

时间窗: First day

This form, which was created by the researchers by scanning the literature, consists of two parts. In the first part, seven questions to determine the introductory characteristics of the elderly (age, gender, marital status, place of residence, education level, occupation, smoking and alcohol use); In the second part, there are a total of 13 questions, six of which are aimed at determining the diabetes characteristics of the elderly (duration of diabetes, type of treatment, regular application of treatment, presence of other chronic diseases, attention to diet, regular exercise).

Blood Parameters Follow-up Form

时间窗: First week

This form was created by the researcher by scanning the literature to record and monitor the blood parameters of the elderly with diabetes. in form; There are seven values including glycosylated hemoglobin (HbA1C/%), fasting plasma glucose (APG/mg/dl), triglyceride (TG/mg/dl), high-density lipoprotein (HDL/mg/dl), low-density lipoprotein (LDL/mg/dl), creatinine mg/dl and urea mg/dl values of the elderly. These seven values are routinely requested from all patients who come to Bayburt State Hospital Internal Medicine Outpatient Clinic with the diagnosis of Type 2 diabetes and the results are recorded in the computer environment. Blood parameter results will be taken from the computer environment and recorded by the researcher.

次要结局

  • Diabetes Symptoms Checklist Scale(Twelfth week)
  • Blood Parameters Follow-up Form(Twelfth week)

研究者

发起方
Bayburt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine APAYDIN

Lecturer

Bayburt University

研究点 (2)

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