- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05630417
Investigation of the Effect of Geriatric Massage
Investigation of the Effect of Geriatric Massage Applied to the Elderly With Type 2 Diabetes on Diabetes Symptoms and Blood Parameters
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bayburt, Turkey, 69000
- Bayburt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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".
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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