Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathy, Diabetic
- Sponsor
- Hacettepe University
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Change in pain severity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Nur Izgu
Assistant professor
Hacettepe University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in pain severity
Time Frame: 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 Outcomes
- Change in Quality of life status(baseline measurements, at the end of 12th week and two weeks after the completion of the interventions)
- Change in fatigue severity(Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions)