Neuropathy, Diabetic
Conditions
Keywords
Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.
Brief summary
Patients with painful diabethic peripheral neuropathy will be entered.. Participants will be randomized to one of three study arms: Arm 1: relaxatio; Arm 2:meditation Arm 3: Attention matched control Hypothesis: Progressive muscle relaxation and mindfullness meditation will decrease severity of neuropathc pain and fatigue and improve quality of life.
Detailed description
Previous reports have revealed that progressive muscle relaxation and meditation are promising for glycemic control in type 2 diabetes patients. On the other hand, research examining effects of these approaches on painful diabetic peripheral neuropathy, fatigue and quality of life is limited. The present study investigates the effects of progressive muscle relaxation and mindfullness meditation in a single-site, 3-arm, assessor blinded randomized, controlled study of 77 type 2 diabetes patients with painful diabetic peripheral neuropathy. Arm 1: relaxation; Arm 2: mindfulness meditation; Arm 3: Attention matched control. The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease severity of neuropathic pain and fatigue and improve quality of life.
Interventions
BEHAVIORALProgressive muscle relaxation
Patients will receive a training session for progressive muscle relaxation exercise They will practice it daily at their home during 12 weeks. Patients will be called daily to ensure that patients perform the intervention according to the study protocol, and to assess their study-adherence.
BEHAVIORALMindfulness meditation
Patients will receive a training session for mindfulness meditation. They will practice it daily at their home during 12 weeks. Patients will be called daily to ensure that patients perform the intervention according to the study protocol, and to assess their study-adherence.
Patients will receive a training session focusing on focusing on the anatomy and physiological functions of the pancreas, general information about type 2 diabetes including signs, complication, and treatment methods
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being diagnosed with painful diabethic peripheral neuropathy , * being at least primary school graduates, * not using any other complementary or integrative therapy during the study period
Exclusion criteria
* neuropathy history due to any other causes such as megaloblastic anemia, fibromyalgia, autoimmune diseases, hypothyroidism, and lumbar disc hernia * having end-stage of renal failure, chronic obstructive pulmonary disease, advanced cardiac failure, musculoskeletal disorders or depression * having a diabetic foot ulcer or amputation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain severity | Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions | Pain severity will be measured based on patient report by a visual analog scale. Higher score means increase in pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue severity | Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions | Fatigue severity will be measured based on patient report by the Functional Assessment of Chronic Illness- Fatigue Scale. Higher scores indicate that low level of fatigue. |
| Change in Quality of life status | baseline measurements, at the end of 12th week and two weeks after the completion of the interventions | Quality of live will be measured by the Neuropathic Pain Impact on Quality of Life Questionnaire. Higher scores on the scale mean better quality of life. |
Countries
Turkey (Türkiye)
Outcome results
None listed