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
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Sponsor:
Hacettepe University
Information provided by (Responsible Party):
Nur Izgu, Hacettepe University
Tracking Information | |||||
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First Submitted Date ICMJE | February 24, 2020 | ||||
First Posted Date ICMJE | February 27, 2020 | ||||
Last Update Posted Date | February 27, 2020 | ||||
Actual Study Start Date ICMJE | June 8, 2018 | ||||
Actual Primary Completion Date | November 17, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life | ||||
Official Title ICMJE | Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care |
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Condition ICMJE | Neuropathy, Diabetic | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
77 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 17, 2019 | ||||
Actual Primary Completion Date | November 17, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04287439 | ||||
Other Study ID Numbers ICMJE | 3 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Nur Izgu, Hacettepe University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Hacettepe University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hacettepe University | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |