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

Neuropathy, Diabetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287439
• Other study ID #: 3
• Status: Completed
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: November 17, 2019

Study information

• Verified date: February 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 17, 2019
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Fatigue
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Secondary	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.	Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Secondary	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.	baseline measurements, at the end of 12th week and two weeks after the completion of the interventions