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

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
randomized controlled study
Sponsored by
Adiyaman Provincial Health Directorate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Neuropathy, Painful focused on measuring Diabetes, Neuropathic Pain, Foot Reflexology, Foot Bath

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants diagnosed with diabetes and the value of HgbA1c ≥ 6.5, Participants with the DN4 ≥ 4, Participants with the VAS ≥ 4. Exclusion Criteria: 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,

Sites / Locations

  • Reva Gundogan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Foot reflexology group

Foot bath group

Control group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Sensory level
Semmes-Weinstein Monofilament (SWM) Test-During the test, the monofilament designed to apply 10 grams of pressure to the patients is touched to the designated areas of the foot until it forms the letter C. Pressure is applied to three different areas (1st metatarsal head, plantar surface of distal hallux, 5th metatarsal plantar surface) on both feet for one second, sufficient to bend the monofilament, and patients are asked whether they feel this pressure. Expression of pressure by the patient in at least two of the three areas on the plantar surface of the foot indicates sensory loss.
Vibration sense
Vibration Test (128 Hz) diapason-It is applied to the patients in the supine position with 128 Hz Diaposan.The tuning fork is placed perpendicularly and steadily on the dorsal surface of the distal phalanx of the first toe of the foot .The felt vibration time is recorded and if the patient feels the tuning fork vibration after 10 seconds, it is considered as no vibration sense.

Full Information

First Posted
February 1, 2023
Last Updated
June 17, 2023
Sponsor
Adiyaman Provincial Health Directorate
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1. Study Identification

Unique Protocol Identification Number
NCT05920434
Brief Title
The Effect of Foot Reflexology and Foot Bath on Paın And Qualıty of Lıfe Applıed to Dıabetıc Neuropathıc Paın
Official Title
Gaziantep University's Clinical Research Ethics Committee
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2020 (Actual)
Primary Completion Date
August 21, 2020 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman Provincial Health Directorate

4. Oversight

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

5. Study Description

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.
Detailed Description
(I) Foot reflexology group 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. (II) Foot bath group In the first meeting, each patient in the foot bath group was informed about the way of doing a footbath in practice. Each patient 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 patients (Figure 2D). In order not to miss the applications, the patient was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). The patient 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 25. The patient came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week. Control group Forms and protective sensory examination tests were applied to the patients in the control group, as in the intervention groups, and no application was made other than standard nursing care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
Keywords
Diabetes, Neuropathic Pain, Foot Reflexology, Foot Bath

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foot reflexology group
Arm Type
Experimental
Arm Description
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).
Arm Title
Foot bath group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
randomized controlled study
Intervention Description
randomized controlled study,no drugs or devices were administered to the participants.
Primary Outcome Measure Information:
Title
Pain scores
Description
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.
Time Frame
6 weeks
Title
Pain severity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sensory level
Description
Semmes-Weinstein Monofilament (SWM) Test-During the test, the monofilament designed to apply 10 grams of pressure to the patients is touched to the designated areas of the foot until it forms the letter C. Pressure is applied to three different areas (1st metatarsal head, plantar surface of distal hallux, 5th metatarsal plantar surface) on both feet for one second, sufficient to bend the monofilament, and patients are asked whether they feel this pressure. Expression of pressure by the patient in at least two of the three areas on the plantar surface of the foot indicates sensory loss.
Time Frame
6 weeks
Title
Vibration sense
Description
Vibration Test (128 Hz) diapason-It is applied to the patients in the supine position with 128 Hz Diaposan.The tuning fork is placed perpendicularly and steadily on the dorsal surface of the distal phalanx of the first toe of the foot .The felt vibration time is recorded and if the patient feels the tuning fork vibration after 10 seconds, it is considered as no vibration sense.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
The quality of life
Description
Neuropathic Pain Impact on Quality-of-Life Questionnaire (NePIQoL)-The scale consists of 42 items in total and the item answer options are in the form of a 5-point Likert scale.Except for items 12, 15, 33, 34, which are reverse scored, all items are scored from 5-1; 5 is 'strongly agree' or 'always' and 1 is 'strongly disagree' or 'no, never'. The total score range varies between 42 and 210 .A high score on the scale indicates a low quality of life.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with diabetes and the value of HgbA1c ≥ 6.5, Participants with the DN4 ≥ 4, Participants with the VAS ≥ 4. Exclusion Criteria: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reva Gundogan, Expert Nurse
Organizational Affiliation
Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician
Official's Role
Study Chair
Facility Information:
Facility Name
Reva Gundogan
City
Adıyaman
ZIP/Postal Code
02100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be stored by researchers.
Citations:
PubMed Identifier
31639839
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31639839/
Description
Google internet link

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

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