Foot Reflexology in Diabetic Patients With Neuropathic Pain

NCT05878431 | Completed

• 1 other identifier: Reflexology
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Patient Engagement; Reflexology

Keywords

Reflexology; Diabetes Mellitus; Neuropathic Pain; Hope; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental groups

EXPERIMENTAL

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

Control groups

NO INTERVENTION

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

Interventions

Foot Reflexology OTHER

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.

Experimental groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus State Hospital

Muş, Muş, 49000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Patient Participation; Neuralgia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this study, patients were randomized to the experimental and control groups by using a simple random numbers table from the computer-assisted randomization program in accordance with the simple random sampling method. In this study, participants in the experimental and control groups were blind to each other; however, the researcher was not blinded to the group allocation as he was also the practitioner.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study was conducted as a single-blind randomized controlled study with pretest-posttest

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 26, 2023
• Study Start: January 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 11, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)