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

Primary Purpose

Neuropathy, Diabetic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive muscle relaxation
Mindfulness meditation
Attention matched control
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathy, Diabetic focused on measuring Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Relaxation

Meditation

Attention matched control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in pain severity
Pain severity will be measured based on patient report by a visual analog scale. Higher score means increase in pain severity.

Secondary Outcome Measures

Change in fatigue severity
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
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.

Full Information

First Posted
February 24, 2020
Last Updated
February 25, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04287439
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2018 (Actual)
Primary Completion Date
November 17, 2019 (Actual)
Study Completion Date
November 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Diabetic
Keywords
Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation
Arm Type
Experimental
Arm Description
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.
Arm Title
Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention matched control group
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Mindfulness meditation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention matched control
Intervention Description
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 Outcome Measure Information:
Title
Change in pain severity
Description
Pain severity will be measured based on patient report by a visual analog scale. Higher score means increase in pain severity.
Time Frame
Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Secondary Outcome Measure Information:
Title
Change in fatigue severity
Description
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.
Time Frame
Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Title
Change in Quality of life status
Description
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.
Time Frame
baseline measurements, at the end of 12th week and two weeks after the completion of the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Izgu, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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