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

Not Applicable

Completed

• Conditions: Neuropathy, Diabetic
• Interventions: Other: Attention matched control; Behavioral: Progressive muscle relaxation; Behavioral: Mindfulness meditation

• Registration Number: NCT04287439
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-08
• Primary Completion: 2019-11-17
• Study Completion: 2019-11-17
• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-27
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention matched control group	Attention matched control	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.
Relaxation	Progressive 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.
Meditation	Mindfulness meditation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit; 🇹🇷 Ankara, Turkey