Effect of Self-Foot Massage on Diabetic Individuals

NCT ID: NCT04906226

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-07-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Self-foot massage

Intervention Type: BEHAVIORAL

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aksaray University

OTHER

Sponsor Role: lead

Responsible Party

KADRİYE SAYIN KASAR

PhD, RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kadriye SAYIN KASAR, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Aksaray University

Locations

Aksaray University

Aksaray, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-020

Identifier Type: -

Identifier Source: org_study_id