NCT04287439

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

Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathy, Diabetic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-08
• Primary completion: 2019-11-17
• Completion: 2019-11-17
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

1 site across 1 country: Turkey (Türkiye)