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Clinical Trials/NCT04477278
NCT04477278
Completed
Not Applicable

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

University of Utah1 site in 1 country39 target enrollmentMarch 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of Utah
Enrollment
39
Locations
1
Primary Endpoint
Change in Pain Intensity from immediately before session to immediately after
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2019
End Date
June 23, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Hanley

Assistant Professor

University of Utah

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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))
  • Patient Satisfaction(Immediately after the osteopathic manipulation session)
  • 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))
  • 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))

Study Sites (1)

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