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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Satisfaction, Patient

Intervention / Treatment
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* Behavioral: Mindfulness Meditation
* Behavioral: History of Osteopathy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio-Guided Mindfulness Intervention<br>Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation. | Behavioral: Mindfulness Meditation<br>* 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.<br>|
| Active Comparator: History of Osteopathy<br>Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation. | Behavioral: History of Osteopathy<br>* The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity from immediately before session to immediately after | Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain. | Immediately before and after the osteopathic manipulation session (i.e., 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after | 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. | Immediately before and after the osteopathic manipulation session (i.e., 1 hour) | 
| Patient Satisfaction | 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. | Immediately after the osteopathic manipulation session | 
| Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after | 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. | Immediately before and after the pre-session audio recording (i.e., 10 minutes) | 
| Change in Embodied Safety from immediately before pre-session audio recording to immediately after | 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. | Immediately before and after the pre-session audio recording (i.e., 10 minutes) |