Foot Reflexology in Diabetic Patients with Neuropathic Pain

February 7, 2025 updated by: Cihat Demirel, Muş Alparslan University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: At the end of the 6-week intervention
At the end of the 6-week intervention
Herth Hope Scale
Time Frame: At the end of the 6-week intervention
At the end of the 6-week intervention
Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)
Time Frame: At the end of the 6-week intervention
At the end of the 6-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muş Alparslan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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