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OpenTrials
Completed

NCT Number: NCT04477278

Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation

This is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients scheduled for OMT at the Huntsman Cancer Institute

Exclusion criteria

  • Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.

Treatment and study plan

Mindfulness Meditation

Behavioral

The mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.

History of Osteopathy

Behavioral

The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.

Primary outcomes

  1. Change in Pain Intensity from immediately before session to immediately after

    Time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)

    Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain.

Secondary outcomes

  1. Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after

    Time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)

    The sensation manikin is a digital human figure silhouette that is overlaid with a grid of 786 "sensation" pixels. Participants identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once on any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice on any grid pixel turns that location red, indicating an unpleasant sensation. Each participant was instructed to color the entire area in which they were currently feeling sensation in their body. A clinically useful sensation ratio score is achieved by dividing the number of pleasant sensation pixels reported by the number of unpleasant sensation pixels reported. Higher scores indicate a larger pleasant sensation to unpleasant sensation ratio.

  2. Patient Satisfaction

    Time frame: Immediately after the osteopathic manipulation session

    Session satisfaction was measured with an individual item ("I am satisfied with my treatment session.") rated on a numeric rating scale (0-10). Higher scores indicate greater satisfaction.

  3. Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after

    Time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)

    Mindfulness of the body was measured with an individual item ("I felt in contact with my body") from the State Mindfulness Scale (Tanay & Bernstein, 2013) rated on a numeric rating scale (0-10). Higher scores indicate more mindfulness of the body.

  4. Change in Embodied Safety from immediately before pre-session audio recording to immediately after

    Time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)

    Embodied safety was measured with an individual item ("I felt my body was a safe place."), from the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012) rated on a numeric rating scale (0-10). Higher scores indicate greater embodied safety.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 20, 2020
Registry last updated
Jul 20, 2020

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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