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Clinical Trials/NCT05577377
NCT05577377CompletedPhase 1

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 site in 1 country28 target enrollmentStarted: March 23, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Correlation between OM and PTSD symptoms

Study Overview

Brief Summary

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

OM intervention

Experimental

Intervention: Orgasmic Meditation (Behavioral)

Outcomes

Primary Outcomes

Correlation between OM and PTSD symptoms

Time Frame: 4 weeks

Change in PCL-5 Score

Number of participants who withdraw from the study

Time Frame: 4 weeks

Safety will be measured by completion rate

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

Time Frame: 4 weeks

feasibility measured by OM perceived value survey

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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