Effect of Self-Foot Massage on Diabetic Individuals

NCT04906226 | Completed

• 1 other identifier: 2021-020
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Type 2 diabetes; Foot massage; Neuropathic pain; Skin temperature; Comfort

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Self-foot massage 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University: lead

Study Sites (1)

Aksaray University

Aksaray, 68100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Neuralgia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kadriye SAYIN KASAR, PhD, RN

  Aksaray University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Model Details: A Randomized Controlled Trial

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 28, 2021
• Study Start: August 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)