Effect of Self-Foot Massage on Diabetic Individuals

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Self-foot massage

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kadriye SAYIN KASAR, PhD,RN; Phone Number: +90 0382 2882785; Email: kadriye_syn_321@hotmail.com
• Study Contact Backup: Name: Aksaray University

Study Locations

• Turkey
  • Aksaray, Turkey, 68100
    • Recruiting
    • Aksaray University
    • Contact: Kadriye SAYIN KASAR, PhD, RN; Phone Number: +90 05068662450; Email: kadriye_syn_321@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
DN4 Pain Questionnaire	The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.	1 months
General Comfort Questionnaire- Short form	It is used to determine the comfort level of patients.	1 months
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

Collaborators and Investigators

• Sponsor: Aksaray University
• Investigators: Principal Investigator: Kadriye SAYIN KASAR, PhD, RN, Aksaray University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Neuropathic pain; Comfort; Foot massage; Skin temperature
• Other Study ID Numbers: 2021-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No