Clinical trial NCT04287439: Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life
Official title: Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy, Diabetic
Keywords: Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in pain severity
timeFrame: Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Secondary outcomes:
measure: Change in fatigue severity
timeFrame: Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
measure: Change in Quality of life status
timeFrame: baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit
Study officials:
affiliation: Hacettepe University
name: Nur Izgu, PhD
role: PRINCIPAL_INVESTIGATOR
References: