Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life

Hacettepe University

Status: Completed

Conditions: Neuropathy, Diabetic

Treatments: Other: Attention matched control; Behavioral: Progressive muscle relaxation; Behavioral: Mindfulness meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04287439

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 3 patient groups

Relaxation

Experimental group

Description:

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.

Treatment:

Behavioral: Progressive muscle relaxation

Meditation

Experimental group

Description:

Patients will receive a training session for minfullness 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.

Treatment:

Behavioral: Mindfulness meditation

Attention matched control group

Active Comparator group

Description:

Patients will receive a training session focusing on the anatomy and physiological functions of the pancreas, general information about type 2 diabetes including signs, complication, and treatment methods.

Treatment:

Other: Attention matched control