The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain
Withdrawn before enrolling · Not applicable
Conditions studied: Fibromyalgia
In brief
The purpose of this study is to examine the effects of a brief mindfulness meditation intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to a wait-list control condition. Based on prior research, investigators' working hypothesis is that this intervention will decrease the severity of FM-associated clinical pain and experimentally induced pain in comparison to pre-intervention scores and a wait-list control group. Additionally, based on prior work, investigators postulate that mindfulness meditation training will decrease a) depression, b) state anxiety, c) overall disease severity, and d) perceived stress, while increasing e) quality of sleep, and f) mindfulness skills in comparison to pre-intervention scores and the wait-list control group. Investigators will also be testing if decreases in pain ratings during meditation correspond to increases in parasympathetic activity. The relative systemic contributions of the parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart rate variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic activity. Importantly, decreased HF HRV correlates with increased pain. Investigators therefore will employ psychophysical and physiological methodologies to test the hypothesis that the analgesic effects of mindfulness meditation in FM patients are associated with increases in HF HRV.
Key facts
- Study ID
- NCT02581332
- Run by
- Wake Forest University Health Sciences
- People needed
- 0
- Starts
- 2017-01-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2017-11-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Sixty individuals (18-65 years old; male and female) of all ethnic backgrounds will be examined.
- Participants should meet the 2010 revised American College of Rheumatology (ACR) criteria for FM.
- Additionally, only patients who have been on the same medication regimen for FM for the past four weeks will be included.
- Patients must also report a score of greater than or equal to 50 on the Revised FM Impact Questionnaire (FIQR) and a score of less than 20 on the Patient Health Questionnaire-8 (PHQ-8) to be included in the study.
- Importantly, Dr. Dennis Ang will confirm FM diagnoses.
You may not qualify if…
- Individuals with chronic heart or lung conditions, who are pregnant, smoke, are currently waiting for a response to an application for disability, have been diagnosed with schizophrenia, bipolar, or any other mental illness or personality disorder, or are planning on undergoing any major elective surgery in the next three months will be excluded.
- Additionally, those patients who have ever meditated (excluding yoga) will be excluded.
Where it is running
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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