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

NCT ID: NCT05920434

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-19
• Study Completion Date: 2021-03-22

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.

Conditions

Diabetic Neuropathy, Painful

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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 (28,29) (Figure 2C).

Group Type: EXPERIMENTAL

randomized controlled study

Intervention Type: OTHER

randomized controlled study,no drugs or devices were administered to the participants.

Foot bath group

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.

Group Type: EXPERIMENTAL

randomized controlled study

Intervention Type: OTHER

randomized controlled study,no drugs or devices were administered to the participants.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

randomized controlled study

randomized controlled study,no drugs or devices were administered to the participants.

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman Provincial Health Directorate

OTHER

Sponsor Role: lead

Responsible Party

Reva Gündoğan

Expert Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reva Gundogan, Expert Nurse

Role: STUDY_CHAIR

Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician

Locations

Reva Gundogan

Adıyaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31639839 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/31639839/

Google internet link

Other Identifiers

Manuscript: NS-D-22-012

Identifier Type: -

Identifier Source: org_study_id