The Effect of Foot Reflexology and Foot Bath on Paın And Qualıty of Lıfe Applıed to Dıabetıc Neuropathıc Paın

NCT05920434 | Completed DMC

• 1 other identifier: Manuscript: NS-D-22-012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Pain relief in diabetic neuropathy is one of the main goals of treatment. Foot reflexology and foot bath, which are two of the important applications of holistic approaches, reduce pain and can significantly increase the quality of life. Objective: In the current study, it was aimed to examine the effects of foot reflexology and foot bath applied to diabetic individuals with neuropathic pain on pain and quality of life. Method: In this randomized controlled study, the sample was randomized into three groups: (I) Foot reflexology (n: 30), (II) Foot bath (n: 30), and (III) Control (n: 30). The "Patient Information Form", "DN4 Pain Questionnaire", "Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL)", and "Visual Analog Scale (VAS)" were used to collect research data. In the study, a protective sensory examination was also performed with the Semmes-Weinstein Monofilament (SWM) Test and the Vibration Test (128 Hz diapason). Apart from these, foot care training was given to all patients included in the practice groups as the role of the diabetes nurse, based on the diabetic foot care training prepared by the Turkish Diabetes Association.

Conditions

Diabetic Neuropathy, Painful

Keywords

Diabetes; Neuropathic Pain; Foot Reflexology; Foot Bath

Outcome Measures

Primary Outcomes (2)

• Pain scores

  Douleur Neuropathique 4 Questions -It consists of 10 questions in total. The total scale score is calculated by giving 1 point for the yes answer given by the patient to each of the questions and examination findings, and 0 points for the no answer. The lowest score is 0, the highest 10 points can be obtained. is evaluated.

  6 weeks

• Pain severity

  Visual Analog Scale (VAS)-It is an equidistant scale on a 10 cm horizontal plane, on one side of which there is no pain and on the other side the pain is "unbearable". The patient is asked to mark the point on this line that best expresses the severity of his or her pain. This distance, measured in millimeters, is interpreted as a "score" .For pain severity, 0 points are "no pain" and 10 points are "worst unbearable pain". evaluated as.

  6 weeks

Secondary Outcomes (2)

• Sensory level

  6 weeks

• Vibration sense

  6 weeks

Other Outcomes (1)

• The quality of life

  6 weeks

Study Arms (3)

Foot reflexology group

EXPERIMENTAL

Individuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks (28,29) (Figure 2C).

Other: randomized controlled study

Foot bath group

EXPERIMENTAL

In the first meeting, each participant in the foot bath group was informed about the way of doing a footbath in practice. Each participant in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the participant s (Figure 2D). In order not to miss the applications, the participant was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). Th participant was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle (24). The participant came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week.

Other: randomized controlled study

Control group

NO INTERVENTION

Forms and protective sensory examination tests were applied to the participant s in the control group, as in the intervention groups, and no application was made other than standard nursing care.

Interventions

randomized controlled study OTHER

randomized controlled study,no drugs or devices were administered to the participants.

Foot bath group; Foot reflexology group

Eligibility Criteria

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

You may qualify if:

• Participants diagnosed with diabetes and the value of HgbA1c ≥ 6.5,
• Participants with the DN4 ≥ 4,
• Participants with the VAS ≥ 4.

You may not qualify if:

• Participants who were pregnant
• Participants who received any other complementary therapy during the period of the study,
• Participants who had history of systolic blood pressure lower than 100 mmHg in the past,
• Participants who were taking systemic corticosteroids in the previous month,
• Participants who with peripheral artery disease, gonarthrosis, spinal disc herniation, ankle tendonitis, active foot ulcer, and infection
• Participants who had histories of Kidney, heart and brain diseases, rheumatic diseases, thyroid diseases, other hormonal disorders, and malignancy,

Sponsors & Collaborators

• Adiyaman Provincial Health Directorate: lead

Study Sites (1)

Reva Gundogan

Adıyaman, 02100, Turkey (Türkiye)

Location

Related Publications (1)

• Zakin E, Abrams R, Simpson DM. Diabetic Neuropathy. Semin Neurol. 2019 Oct;39(5):560-569. doi: 10.1055/s-0039-1688978. Epub 2019 Oct 22.

  PMID: 31639839 BACKGROUND

Related Links

• Google internet link

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Reva Gundogan, Expert Nurse

  Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Expert Nurse

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: June 27, 2023
• Study Start: July 19, 2020
• Primary Completion: August 21, 2020
• Study Completion: March 22, 2021
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)