Pain, Satisfaction, Patient
Conditions
Brief summary
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.
Interventions
BEHAVIORALMindfulness Meditation
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.
BEHAVIORALHistory of Osteopathy
The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity from immediately before session to immediately after | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after | 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. |
| Patient Satisfaction | 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. |
| Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after | 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. |
| Change in Embodied Safety from immediately before pre-session audio recording to immediately after | 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. |
Countries
United States
Outcome results
None listed