The Relationship Between Stress Scores, a Single-session of Chiropractic Care, Heart Rate Variability, and Electroencephalography Patterns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Electroencephalography Power spectrum
研究概览
简要总结
The Life University Center for Chiropractic Research is conducting a study to better understand the relationship between subjective stress measures and brain patterns during resting state and an auditory oddball task. A secondary aim is to evaluate the impact of a single session of chiropractic care on the resting state and P300 time locked response after a one-week wait period. An additional outcome assessment for this study will be the recording of an electrocardiogram (ECG) of each participant that will be used to analyze their heart rate variability (HRV). Eligible individuals will receive a physical exam to ensure safety during all procedures. They will then sit for a 6-minute resting state EEG and an auditory oddball task. They will complete a series of questionnaires assessing stress. They will receive a chiropractic adjustment using a handheld instrument called an Activator. They will return one week later for a follow-up assessment consisting of the 6-minute resting state EEG, auditory oddball task, and the questionnaires assessing stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between the ages of 18 and 40
- •Individuals who can wear an EEG cap for 40 minutes
- •Individuals who can sit quietly for at least 15 minutes
- •Individuals who have not had a chiropractic adjustment within the last two weeks
- •Individuals who have not received any other interventions, such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies or acupuncture within the last 2 weeks.
排除标准
- •Individuals who have been diagnosed with a serious mental disorder such as schizophrenia or major depressive disorder that could influence EEG results
- •Individuals who do not feel they can sit quietly with limited movement for roughly 15 minutes
- •Individuals who are on psychotropic medications (e.g. Benzodiazepine medications) that influence EEG readings (Benzodiazepine medications include but are not limited to: alprazolam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, oxazepam, temazepam, triazolam, etc.)
- •Individuals with any injury or surgery to the skull in the last 6 months, or a history of trauma to the head such as a concussion or stroke
- •Individuals with a hearing impairment (due to the auditory stimulus recording being performed)
- •Individuals who are currently pregnant
- •Individuals with a current litigation related to a physical, health-related injury
- •Individuals with untreated diagnosed osteoporosis or articular instability, such as atlanto-axial instability
- •Individuals with a known heart condition that results in an aberrant ECG recording
结局指标
主要结局
Electroencephalography Power spectrum
时间窗: one-week (post)
6 minutes of resting state EEG with eyes closed. 64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Heart rate variability (HRV)
时间窗: one-week (post)
ECG recording will be used to evaluate HRV from R-R intervals.
Brief Resilience Scale
时间窗: one-week (post)
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
Hamilton Anxiety Rating Scale
时间窗: one-week (post)
14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Connor Davidson Resilience Scale - 25
时间窗: one-week (post)
25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Weekly Stress Inventory Short Form
时间窗: one-week (post)
25 questions. Likert scale: did not happen; happended but not successful; slightly stressful; mildly stressful; moderately stressful; stressful; very stressful; extremely stressful.
Daily Stress Scale
时间窗: one-week (post)
6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.
Auditory oddball task
时间窗: one-week (post)
Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.
Severity of Acute Stress Symptoms
时间窗: one-week (post)
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
次要结局
未报告次要终点