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Completed

NCT Number: NCT04906226

Effect of Self-Foot Massage on Diabetic Individuals

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Visuel Analog Scale- (VAS)

    Time frame: 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.

  2. DN4 Pain Questionnaire

    Time frame: 1 months

    The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.

  3. General Comfort Questionnaire- Short form

    Time frame: 1 months

    It is used to determine the comfort level of patients.

  4. Peripheral skin temperature will be measured with a skin thermometer

    Time frame: 1 months

    The skin temperature in the middle of the plantar surfaces of both feet is measured using the handheld digital skin thermometer.

Sponsors and collaborators

Lead sponsor

Aksaray University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 28, 2021
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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