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NCT Number: NCT04287439

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

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.

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Key information

Conditions

Neuropathy, Diabetic Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Fatigue Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Muscle Relaxation

Behavioral

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.

Mindfulness Meditation

Behavioral

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.

Attention matched control

Other

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

Primary outcomes

  1. 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

  1. Change in fatigue severity

    Time frame: 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.

  2. Change in Quality of life status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2020
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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