Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital
Bolu, Turkey (Türkiye)
NCT Number: NCT05647083
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.
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Notify Me30 year–75 year
All sexes
Interventional
Not applicable
Bolu, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.
Time frame: Change from baseline Neuropathy score at 3 months
Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score;
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
Time frame: Change from baseline Ankle-Brachial Index score at 3 months
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.
Time frame: Change from baseline HbA1c score at 3 months
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.
Time frame: Change from baseline systolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Time frame: Change from baseline diastolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Time frame: Change from baseline heart rate at 3 months
It will be measured by the researcher with a pulse oximeter.
Time frame: Change from baseline oxygen saturation at 3 months
It will be measured by the researcher with a pulse oximeter.
Time frame: Change from baseline diabetic foot risk score at 3 months
"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.
Abant Izzet Baysal University
Other
The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes
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