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临床试验/NCT05577377
NCT05577377已完成1 期

An Unblinded, Uncontrolled, 1-month Interventional Single Group Pilot Study, to Assess the Possibility of Orgasmic Meditation Practice Being Used as a Possible Intervention for PTSD.

Institute of OM Foundation1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年3月23日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
28
试验地点
1
主要终点
Correlation between OM and PTSD symptoms

研究概览

简要总结

The primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. The secondary purpose of this study is to examine if OM is associated with a decrease in the symptoms and self-assessed experiences associated with trauma.

The OM Trauma Protocol (OMTP) is designed to systematize the application of Orgasmic Meditation (OM) for individuals seeking relief from a wide variety of problems and/or help them in their pursuit of eudaimonia. The study protocol will evaluate whether OMing (the act of practicing OM) shows potential for being an effective intervention for people suffering from Post-Traumatic Stress Disorder (PTSD).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults ≥18 years old
  • •One or more participants of the pair having a diagnosis of PTSD for > 6 months
  • •Relationship for > 6 months
  • •Self or partner of female sex
  • •Massachusetts residents
  • •Access and ability to use internet and a video platform called Zoom
  • •No history of doing the practice of OM

排除标准

  • •Ongoing or active use of illicit drugs at the time of the study
  • •Self-identify as pregnant
  • •Inability to speak English
  • •Recent hospitalization < 12 months
  • •Suicidal ideation < 12 months
  • •Self-harm < 12 months

研究组 & 干预措施

OM intervention

Experimental

干预措施: Orgasmic Meditation (Behavioral)

结局指标

主要结局

Correlation between OM and PTSD symptoms

时间窗: 4 weeks

Change in PCL-5 Score

Number of participants who withdraw from the study

时间窗: 4 weeks

Safety will be measured by completion rate

Number of participants who score a 39 or higher using the OM perceived value survey

时间窗: 4 weeks

feasibility measured by OM perceived value survey

次要结局

  • Correlation between depression and OM(4 weeks)
  • Correlation between anxiety and OM(4 weeks)
  • Correlation between Eudaimonia and OM(4 weeks)
  • Correlation between psychosocial functioning and OM(4 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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