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Trial record 3 of 5 for:    mindfulness and progressive muscle relaxation
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Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life

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ClinicalTrials.gov Identifier: NCT04287439
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nur Izgu, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neuropathy, Diabetic Behavioral: Progressive muscle relaxation Behavioral: Mindfulness meditation Other: Attention matched control Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : November 17, 2019
Actual Study Completion Date : November 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Behavioral: 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.
Experimental: 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.
 Behavioral: Mindfulness meditation
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.
Active Comparator: Attention matched control group
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.
 Other: Attention matched control
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287439


Locations
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Turkey
Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Nur Izgu, PhD Hacettepe University
More Information
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Responsible Party: Nur Izgu, Assistant professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT04287439    
Other Study ID Numbers: 3
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nur Izgu, Hacettepe University:
Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.
Additional relevant MeSH terms:
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Diabetic Neuropathies
Fatigue
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases