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Completed

NCT Number: NCT05577377

OM and Trauma Study

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).

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Institute of OM Foundation

Santa Rosa, California, 95404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Correlation between OM and PTSD symptoms

    Time frame: 4 weeks

    Change in PCL-5 Score

  2. Number of participants who withdraw from the study

    Time frame: 4 weeks

    Safety will be measured by completion rate

  3. 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

  1. Correlation between Eudaimonia and OM

    Time frame: 4 weeks

    Changes in Eudaimonia Assessment

  2. Correlation between depression and OM

    Time frame: 4 weeks

    Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)

  3. Correlation between anxiety and OM

    Time frame: 4 weeks

    Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  4. Correlation between psychosocial functioning and OM

    Time frame: 4 weeks

    Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)

Other outcomes

  1. Correlation between OM and tumescence

    Time frame: 4 weeks

    Changes in the Tumescence Assessment. Tumescence is the measure of internal energy available in a person to be used for creativity and purpose

Sponsors and collaborators

Lead sponsor

Institute of OM Foundation

Industry

Registry information

Official study 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.

Acronym: OMTP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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