Foot Reflexology in Diabetic Patients with Neuropathic Pain

The Effect of Foot Reflexology Applied on Diabetic Patients with Neuropathic Pain on the Patients' Quality of Life, Hope and Pain Levels

This study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels.

This research, which was designed as a randomized controlled and experimental study, was conducted between January 2022 and December 2022. It was determined that foot reflexology application increased the quality of life and hope level of diabetic patients with neuropathic pain and decreased the level of pain.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Patient Engagement; Reflexology
• Intervention / Treatment: Other: Foot Reflexology

Detailed Description

Aim: This study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels.

Material and Method: This research, which was designed as a randomized controlled and experimental study, was conducted between January 2022 and December 2022. The data of the study consisted of 102 diabetic patients with neuropathic pain, 51 of whom were experimental and 51 were controls. As data collection tools; Patient Information Form, Herth Hope Scale (HHI), Four-Question Neuropathic Pain Questionnaire (DN4Q), Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL), and Visual Analog Scale (VAS) were used. A total of 12 sessions of foot reflexology were applied to the patients in the experimental group, twice a week for 6 weeks. No intervention was performed on the patients in the control group.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muş, Turkey, 49000
    • Mus State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years old and over
• Do not have any physical or mental illness that will prevent communication,
• Diabetic neuropathic pain [with a total score of at least 4 and above according to the Four-Question Neuropathic Pain Questionnaire (DN4Q)]
• Patients who can read, write and speak Turkish

Exclusion Criteria:

• Complications developing during reflexology practice,
• Not attending at least one of the practice sessions,
• It was planned to exclude patients who wanted to leave at any stage of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental groups; patients in the experimental group during the pre-test phase; "Patient Information Form", "Herth Hope Scale", "Four-Question Neuropathic Pain Questionnaire (DN4Q)", "The Effect of Neuropathic Pain on Quality of Life Questionnaire (NePIQOL)" and "Visual Analog Scale (VAS)" were administered by face-to-face interview technique. Then to the patients in the experimental group; A total of 12 sessions of foot reflexology, two sessions per week, were applied for 6 weeks. patients in the experimental group during the pos-test phase; "Herth Hope Scale", "Four-Question Neuropathic Pain Questionnaire (DN4Q)", "The Effect of Neuropathic Pain on Quality of Life Questionnaire (NePIQOL)" and "Visual Analog Scale (VAS)" were administered by face-to-face interview technique	Other: Foot Reflexology; The patients in the experimental group underwent 12 sessions of foot reflexology in a quiet room, twice a week, for 6 weeks. No application was made to the patients in the control group. FOOT REFLEXOLOGY APPLICATION STAGES; Application of heating methods such as Achilles tendon stretching, wrist loosening, walking the thumbs of both hands on the soles of the feet and wringing the laundry, which lasts about 3 minutes,; Pressure on the brain, cervical region, solar plexus (the projection of the central nervous system on the sole of the foot), lymph system, adrenal glands, urinary system, digestive system, sciatic nerve, hips, knees and reflex points on the soles of the legs for about 10-15 minutes. implementation (Figure 3.4),; Ending the application by applying heating methods such as Achilles tendon stretching, wrist loosening, walking the thumbs of both hands on the soles of the feet and wringing the laundry, which lasts approximately 3 minutes after the application.
No Intervention: Control groups; patients in the control group at the pre-test stage; "Patient Information Form", "Herth Hope Scale", "Four-Question Neuropathic Pain Questionnaire (DN4Q)", "The Effect of Neuropathic Pain on Quality of Life Questionnaire (NePIQOL)" and "Visual Analog Scale (VAS)" were applied. with face-to-face interview technique. patients in the control group during the pos-test phase; "Herth Hope Scale", "Four-Question Neuropathic Pain Questionnaire (DN4Q)", "The Effect of Neuropathic Pain on Quality of Life Questionnaire (NePIQOL)" and "Visual Analog Scale (VAS)" were administered by face-to-face interview technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vizüel Analog Scale (VAS)	At the end of the 6-week intervention
Herth Hope Scale	At the end of the 6-week intervention
Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)	At the end of the 6-week intervention

Collaborators and Investigators

• Sponsor: Muş Alparslan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Diabetes Mellitus; Reflexology; Neuropathic Pain; Hope
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Peripheral Nervous System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Neuralgia
• Other Study ID Numbers: Reflexology

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
• product manufactured in and exported from the U.S.: No