Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
研究概览
简要总结
Motion sickness directly impacts the readiness of the Army's aviation units. Severe motion sickness results in the dismissal of pilot and air crew candidates during initial training, while minor to moderate symptoms can be distracting during flight. The current medications on the market that target motion sickness symptoms are prohibited for use before flight. Osteopathic Manipulative Techniques are a low to no cost option, which lacks side effects, that allows Doctor of Osteopathic Medicine flight surgeons the opportunity to treat crew members without the use of pharmaceuticals. If effective, these techniques could be used to ensure aircrew readiness. Given the paucity of research on such a technique, a small, pilot study was conducted to demonstrate potential for such an approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants received treatment in private room. Study team and participants were blind to group (treatment received). Only the treatment administrator knew which treatment each participant received and was excluded from the remainder of the protocol.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and review on demographics and personal history questionnaire.
- •Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by self-report.
- •Must have refrained from consumption of alcohol and Medications that impact motion sickness symptoms for a minimum of 16 hours prior to each test session, assessed by self-report.
排除标准
- •Must not be currently taking any medications that may affect the vestibular system as assessed by self-report and at the discretion of the study physician.
- •Must not have a history of vestibular disorders as assessed by self-report.
结局指标
主要结局
Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
时间窗: Administered immediately pre and post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure
时间窗: Administered immediately pre and post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: peripheral subscore from pre- to post-procedure
时间窗: Administered immediately pre and post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: sopite-related subscore from pre- to post-procedure
时间窗: Administered immediately pre and post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: total subscore from pre- to post-procedure
时间窗: Administered immediately pre and post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Heart rate variability
时间窗: Measured throughout procedure (10 minutes total)
Heart rate was aggregated in 30-second intervals. Coefficients of variance were then calculated across the twenty 30-second intervals per participant.
次要结局
未报告次要终点
研究者
Amanda Kelley
Research Psychologist
United States Army Aeromedical Research Laboratory