OM and Trauma Study

NCT05577377 | Completed Early Phase 1

• 1 other identifier: Pro00061665
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD

Outcome Measures

Primary Outcomes (3)

• Correlation between OM and PTSD symptoms

  Change in PCL-5 Score

  4 weeks

• Number of participants who withdraw from the study

  Safety will be measured by completion rate

  4 weeks

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

  feasibility measured by OM perceived value survey

  4 weeks

Secondary Outcomes (4)

• Correlation between Eudaimonia and OM

  4 weeks

• Correlation between depression and OM

  4 weeks

• Correlation between anxiety and OM

  4 weeks

• Correlation between psychosocial functioning and OM

  4 weeks

Other Outcomes (1)

• Correlation between OM and tumescence

  4 weeks

Study Arms (1)

OM intervention

EXPERIMENTAL

Behavioral: Orgasmic Meditation

Interventions

Orgasmic Meditation BEHAVIORAL

Orgasmic Meditation (OM) is a structured attention training practice that you do with another person by following a predefined set of detailed instructions. One of the two people participating in the OM must have a clitoris. In this partnered practice, one person strokes the clitoris of another person with the tip of their left index finger for 15 minutes.

OM intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: One of the participant pairs must have a clitoris
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of OM Foundation: lead

Study Sites (1)

Institute of OM Foundation

Santa Rosa, California, 95404, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Dan Kriegman, PhD

  Institute of OM Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre and Post Intervention Study with Orgasmic Meditation - a meditation practice

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 13, 2022
• Study Start: March 23, 2022
• Primary Completion: April 18, 2024
• Study Completion: August 25, 2024
• Last Updated: September 20, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)