The Effect of Massage on Diabetic Parameters

Study Overview
=================
Brief Summary
-----------------
This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine Service. According to power analysis, the minimum sample size was determined as 60 people, 30 of which were in the intervention group and 30 in the control group. Data collection tools include Peripheral Neuropathy Sign and Symptom Score, Ankle-Brachial Index (ABI), Glycemic Control Assessment (HbA1c), Physiological Parameters (blood pressure, heart rate and oxygen saturation), Inlow's 60-second Diabetic Food Screen. A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Participants in the control group will continue their medical treatment protocols and massage will not be applied.

Official Title
-----------------
The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Peripheral Neuropathy

Intervention / Treatment
-----------------
* Other: Massage therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being between 30-75 years old, Diagnosed with diabetes at least 6 months ago, Absence of irritation, ulceration in the areas where the massage will be applied (hands, feet and legs), No problem in verbal communication, Being able to speak Turkish, No diagnosis of psychiatric disease, Absence of amputation in the upper and lower extremities, Having HbA1c test results in the last 1 week, Not having had Covid-19 in the last 6 months No experience of massage application in the last 1 month Willingness to participate in the research Exclusion Criteria: Presence of diabetic ulcer and foot wound, Irritation and ulceration in the areas where the massage will be applied (hands, feet and legs), Having problems in verbal communication, Not being able to speak Turkish, Having a diagnosis of psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage. | Other: Massage therapy<br>* Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.<br>|
| No Intervention: Control group<br>Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Means of Peripheral Neuropathy Sign and Symptom Score | Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score; Discomfort they feel in their feet, Location of complaints, The presence of complaints increases at night, Time of occurrence of complaints and 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, normal; 3-4 points, mild neuropathy; 5-6 points, moderate neuropathy; A score of 7-9 will be considered severe neuropathy. For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination | Change from baseline Neuropathy score at 3 months | 
| Means of Ankle-Brachial Index Score | It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1. | Change from baseline Ankle-Brachial Index score at 3 months | 
| Means of HbA1c (%) | HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later. | Change from baseline HbA1c score at 3 months | 
| Means of systolic blood pressure (mmHg) | It will be measured by the researcher with a manual measurement tool. | Change from baseline systolic blood pressure at 3 months | 
| Means of diastolic blood pressure (mmHg) | It will be measured by the researcher with a manual measurement tool. | Change from baseline diastolic blood pressure at 3 months | 
| Means of heart rate (/minutes) | It will be measured by the researcher with a pulse oximeter. | Change from baseline heart rate at 3 months | 
| Means of oxygen saturation (%) | It will be measured by the researcher with a pulse oximeter. | Change from baseline oxygen saturation at 3 months | 
| Means of diabetic foot risk score | Inlow's 60-second Diabetic Food Screen form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot. | Change from baseline diabetic foot risk score at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
massage, glycemic control, diabetic foot risk