Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life
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ClinicalTrials.gov Identifier: NCT04287439 |
Recruitment Status :
Completed
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neuropathy, Diabetic | Behavioral: Progressive muscle relaxation Behavioral: Mindfulness meditation Other: Attention matched control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | June 8, 2018 |
Actual Primary Completion Date : | November 17, 2019 |
Actual Study Completion Date : | November 17, 2019 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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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 |
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287439
Turkey | |
Ankara University Medical Faculty Ibni Sina Hospital Endocrinology Outpatient Unit | |
Ankara, Turkey, 06100 |
Principal Investigator: | Nur Izgu, PhD | Hacettepe University |
Responsible Party: | Nur Izgu, Assistant professor, Hacettepe University |
ClinicalTrials.gov Identifier: | NCT04287439 |
Other Study ID Numbers: |
3 |
First Posted: | February 27, 2020 Key Record Dates |
Last Update Posted: | February 27, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fatigue, meditation, diabetic neuropathy, relaxation, quality of life. |
Diabetic Neuropathies Fatigue Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |