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

Not Applicable

Completed

• Conditions: Satisfaction, Patient; Pain
• Interventions: Behavioral: History of Osteopathy; Behavioral: Mindfulness Meditation

• Registration Number: NCT04477278
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Primary Completion: 2019-09-16
• Study Completion: 2020-06-23
• Status Verified: 2020-07
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
History of Osteopathy	History of Osteopathy	Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation.
Audio-Guided Mindfulness Intervention	Mindfulness Meditation	Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States