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

NCT04287439 | Completed DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy, Diabetic

Keywords

Fatigue, meditation, diabetic neuropathy, relaxation, quality of life.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in fatigue severity

  Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions

• Change in Quality of life status

  baseline measurements, at the end of 12th week and two weeks after the completion of the interventions

Study Arms (3)

Relaxation

EXPERIMENTAL

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

Meditation

EXPERIMENTAL

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

Attention matched control group

ACTIVE COMPARATOR

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.

Other: Attention matched control

Interventions

Progressive muscle relaxation BEHAVIORAL

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.

Relaxation

Mindfulness meditation BEHAVIORAL

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.

Meditation

Attention matched control OTHER

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

Attention matched control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Fatigue

Interventions

Autogenic Training; Mindfulness

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Behavior Therapy

Study Officials

• Nur Izgu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: June 8, 2018
• Primary Completion: November 17, 2019
• Study Completion: November 17, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)