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

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

Tracking Information

• First Submitted Date: February 24, 2020
• First Posted Date: February 27, 2020
• Last Update Posted Date: February 27, 2020
• Actual Study Start Date: June 8, 2018
• Actual Primary Completion Date: November 17, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 25, 2020)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Neuropathy, Diabetic

Intervention

• 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.
• 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.
• 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

Study Arms

• 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.

  Intervention: Behavioral: Progressive muscle relaxation
• 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.
  Intervention: Behavioral: Mindfulness meditation
• 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.
  Intervention: Other: Attention matched control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2020): 77
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 17, 2019
• Actual Primary Completion Date: November 17, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04287439
• Other Study ID Numbers: 3
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Nur Izgu, Hacettepe University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hacettepe University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nur Izgu, PhD; Hacettepe University

• PRS Account: Hacettepe University
• Verification Date: February 2020