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Foot Reflexology in Diabetic Patients With Neuropathic Pain

Primary Purpose

Diabetes Mellitus, Patient Engagement, Reflexology

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foot Reflexology
Sponsored by
Muş Alparlan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus focused on measuring Reflexology, Diabetes Mellitus, Neuropathic Pain, Hope, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mus State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental groups

Control groups

Arm Description

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

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

Outcomes

Primary Outcome Measures

Vizüel Analog Scale (VAS)
Herth Hope Scale
Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
May 18, 2023
Sponsor
Muş Alparlan University
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1. Study Identification

Unique Protocol Identification Number
NCT05878431
Brief Title
Foot Reflexology in Diabetic Patients With Neuropathic Pain
Official Title
The Effect of Foot Reflexology Applied on Diabetic Patients With Neuropathic Pain on the Patients' Quality of Life, Hope and Pain Levels
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muş Alparlan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Patient Engagement, Reflexology
Keywords
Reflexology, Diabetes Mellitus, Neuropathic Pain, Hope, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was conducted as a single-blind randomized controlled study with pretest-posttest
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental groups
Arm Type
Experimental
Arm Description
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
Arm Title
Control groups
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Foot Reflexology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vizüel Analog Scale (VAS)
Time Frame
At the end of the 6-week intervention
Title
Herth Hope Scale
Time Frame
At the end of the 6-week intervention
Title
Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)
Time Frame
At the end of the 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mus State Hospital
City
Muş
ZIP/Postal Code
49000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Foot Reflexology in Diabetic Patients With Neuropathic Pain

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