NCT05630417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

November 17, 2022

Last Update Submit

January 8, 2024

Conditions

Keywords

Blood parametersElderlyGeriatric massageSymptomType 2 Diabetes

Outcome Measures

Primary Outcomes (4)

  • Elderly Information Form

    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)

    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

    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

    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 Outcomes (4)

  • Diabetes Symptoms Checklist Scale

    Forth week

  • Diabetes Symptoms Checklist Scale

    Eighth week

  • Diabetes Symptoms Checklist Scale

    Twelfth week

  • Blood Parameters Follow-up Form

    Twelfth week

Study Arms (2)

Geriatric Massage Group

EXPERIMENTAL

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.

Other: Feet and Back Massage

Control Group

NO INTERVENTION

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.

Interventions

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.

Geriatric Massage Group

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt University

Bayburt, 69000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was planned as a pre test-post test randomized controlled single-center study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 29, 2022

Study Start

March 15, 2022

Primary Completion

August 30, 2023

Study Completion

October 30, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations