OM and Trauma Study

PTSD Clinical Trial

— OMTP  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577377
• Other study ID #: Pro00061665
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 2022
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: Institute of OM Foundation
• Contact: Caroline Griggs, PharmD
• Phone: 4077609386
• Email: caroline[@]iomfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Orgasmic Meditation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of OM Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between OM and tumescence	Changes in the Tumescence Assessment. Tumescence is the measure of internal energy available in a person to be used for creativity and purpose	4 weeks
Primary	Correlation between OM and PTSD symptoms	Change in PCL-5 Score	4 weeks
Primary	Number of participants who withdraw from the study	Safety will be measured by completion rate	4 weeks
Primary	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	Correlation between Eudaimonia and OM	Changes in Eudaimonia Assessment	4 weeks
Secondary	Correlation between depression and OM	Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)	4 weeks
Secondary	Correlation between anxiety and OM	Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)	4 weeks
Secondary	Correlation between psychosocial functioning and OM	Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)	4 weeks