Clinical trial NCT05878431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Patient Engagement
Reflexology
Keywords: Reflexology
Diabetes Mellitus
Neuropathic Pain
Hope
Quality of Life
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a single-blind randomized controlled study with pretest-posttest
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Vizüel Analog Scale (VAS)
timeFrame: At the end of the 6-week intervention
measure: Herth Hope Scale
timeFrame: At the end of the 6-week intervention
measure: Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQOL)
timeFrame: At the end of the 6-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Mus State Hospital
Study officials:
References: