The Effect of Massage on Diabetic Parameters

Abant Izzet Baysal University

Status: Completed

Conditions: Peripheral Neuropathy; Diabetes Mellitus, Type 2

Treatments: Other: Massage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05647083

BAIBU-SBF-EGS-2

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Massage therapy

Control group

No Intervention group

Description:

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.