Effect of Self-Foot Massage on Diabetic Individuals

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Self-foot massage

• Registration Number: NCT04906226
• Lead Sponsor: Aksaray University

Brief Summary

The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes.

Detailed Description

Diabetes mellitus (DM) is the most important metabolic disease that can affect almost every organ system in the body. Although diabetes causes many macrovascular and microvascular complications, one of the rare microvascular complications is peripheral neuropathy. One of the common complementary and integrative applications in the management of diabetic peripheral neuropathy is foot massage. The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. In the collection of data, "Individual Description Form, Visuel Analog Scale- (VAS), DN4 Pain Questionnaire and General Comfort Questionnaire- Short form" will be used. In addition, peripheral skin temperature will be measured with a skin thermometer.

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Study Start: 2021-08-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 18 years of age or above,
• Having been diagnosed with type 2 diabetes at least 6 months ago,
• HbA1c level> 6.5%,
• Being able to do personal care for personal hygiene management,
• No peripheral circulation problems,
• Do not have any problems such as speech or hearing that prevent communication,
• Physical and cognitive health levels are suitable for answering the data collection form,
• Agreeing to participate in the research,
• It is planned to include patients who can speak and understand Turkish.

Exclusion Criteria

• Individuals with other health problems that may cause peripheral neuropathy (chemotherapy, neurological, etc.),
• Patients with organ damage (gangrene or foot / finger amputation) due to diabetes mellitus or any other reason, malignancy, tuberculosis, asthma, or any contagious disease,
• Individuals with a history of disease that may cause changes in peripheral skin temperature (Raynaud's disease, etc.)
• Who do not agree to participate in the research,
• Speaking and hearing impairments that interfere with the collection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Self-foot massage	Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled.

Primary Outcome Measures

Name	Time	Method
Visuel Analog Scale- (VAS)	1 months	The Visual Analogue Scale (VAS), which is used for the assessment of pain, is used to convert some values that cannot be measured numerically into numerical ones.
DN4 Pain Questionnaire	1 months	The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.
Peripheral skin temperature will be measured with a skin thermometer	1 months	The skin temperature in the middle of the plantar surfaces of both feet is measured using the handheld digital skin thermometer.
General Comfort Questionnaire- Short form	1 months	It is used to determine the comfort level of patients.

Trial Locations

Locations (1)

Aksaray University; 🇹🇷 Aksaray, Turkey