Investigation of the Effect of Geriatric Massage

January 8, 2024 updated by: Emine APAYDIN, Bayburt University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bayburt, Turkey, 69000
        • Bayburt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 84 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric Massage Group
The fragility of the elderly, the sensitivity of skin, muscle and bone tissue necessitate modification of massage techniques according to the individual characteristics of the elderly. Geriatric massage is a form of massage applied according to the characteristics of the elderly individual and can be applied to all body parts according to the needs of the elderly. However, since diabetic neuropathy, which is a long-term complication that is common in individuals with Type 2 diabetes and can affect all body parts, shows more symptoms in the feet, foot massage as a geriatric massage may be effective in reducing diabetes symptoms and improving blood parameters. Because of its more systemic effects, back massage was preferred.

Foot massage: Feet are the most neglected organs of people and therefore cause many complaints. Foot massage is a massage applied to the back of the foot, toes, soles of the feet, the muscles between the thumb and little fingers, and the heel, where the muscles between the metatarsal bones are located.

Back massage: Back massage is a non-invasive nursing intervention that can be easily applied by nurses. In back massage application; A 10-minute back massage program applied by Çınar and Eşer (2012) will be applied.

No Intervention: Control Group
No attempt will be made by the researcher on the elderly with Type 2 diabetes in the control group. The elderly in this group will benefit from the standard care practices offered by the institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elderly Information Form
Time Frame: 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).
First day
Standardized Mini Mental Test (SMMT)
Time Frame: 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".
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.]
Diabetes Symptoms Checklist Scale
Time Frame: 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.
First week
Blood Parameters Follow-up Form
Time Frame: 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.
First week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Symptoms Checklist Scale
Time Frame: Forth 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.
Forth week
Diabetes Symptoms Checklist Scale
Time Frame: Eighth 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.
Eighth week
Diabetes Symptoms Checklist Scale
Time Frame: Twelfth 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.
Twelfth week
Blood Parameters Follow-up Form
Time Frame: Twelfth 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.
Twelfth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EAPAYDIN.TEZ-KTÜ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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