Effect of Self-Foot Massage on Diabetic Individuals

Diabetes Mellitus Clinical Trial

Official title:

The Effect of Self-Foot Massage on Peripheral Neuropathic Pain, Peripheral Skin Temperature and Patient Comfort in Diabetic Individuals: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906226
• Other study ID #: 2021-020
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: January 2023
• Source: Aksaray University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Self-foot massage
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.

Locations

Country	Name	City	State
Turkey	Aksaray University	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visuel Analog Scale- (VAS)	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.	1 months
Primary	DN4 Pain Questionnaire	The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.	1 months
Primary	General Comfort Questionnaire- Short form	It is used to determine the comfort level of patients.	1 months
Primary	Peripheral skin temperature will be measured with a skin thermometer	The skin temperature in the middle of the plantar surfaces of both feet is measured using the handheld digital skin thermometer.	1 months