History of Changes for Study: NCT04287439

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

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Version	A	B	Submitted Date	Changes
1			February 25, 2020	None (earliest Version on record)

Study Identification


Unique Protocol ID:	3
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
Secondary IDs:

Study Status


Record Verification:	February 2020
Overall Status:	Completed
Study Start:	June 8, 2018
Primary Completion:	November 17, 2019 [Actual]
Study Completion:	November 17, 2019 [Actual]

First Submitted:	February 24, 2020
First Submitted that Met QC Criteria:	February 25, 2020
First Posted:	February 27, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	February 25, 2020
Last Update Posted:	February 27, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Hacettepe University
Responsible Party:	Principal Investigator Investigator: Nur Izgu Official Title: Assistant professor Affiliation: Hacettepe University
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Conditions


Conditions:	Neuropathy, Diabetic
Keywords:	Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.

Study Design


Study Type:	Interventional
Primary Purpose:	Supportive Care
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	77 [Actual]

Arms and Interventions

Arms	Assigned Interventions
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.	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.
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.	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.
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.	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

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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.
2.	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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Study Officials:	Nur Izgu, PhD Principal Investigator Hacettepe University
Locations:	Turkey
	Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit Ankara, Turkey, 06100

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: