Foot Reflexology in Diabetic Patients With Neuropathic Pain

Diabetes Mellitus Clinical Trial

Official title:

The Effect of Foot Reflexology Applied on Diabetic Patients With Neuropathic Pain on the Patients' Quality of Life, Hope and Pain Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878431
• Other study ID #: Reflexology
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2023
• Source: Mus Alparlan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Neuralgia
• Patient Engagement
• Reflexology

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mus State Hospital	Mus

Sponsors (1)

Lead Sponsor	Collaborator
Mus Alparlan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vizüel Analog Scale (VAS)		At the end of the 6-week intervention
Primary	Herth Hope Scale		At the end of the 6-week intervention
Primary	Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)		At the end of the 6-week intervention