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NCT05647083
The Effect of Massage on Diabetic Parameters
Conditions: Diabetes Mellitus, Type 2, Peripheral Neuropathy
Sex: All
Ages: 30 Years – 75 Years
Phase: NA
Enrollment: 60
Sponsor: Abant Izzet Baysal University
Location: Turkey
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.
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 monthsNo experience of massage application in the last 1 monthWillingness to participate in the researchExclusion 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.
Source: ClinicalTrials.gov (NCT05647083). StuddyBuddy aggregates publicly available trial information.