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.

Study Overview

• Status: Completed
• Conditions: Pain; Satisfaction, Patient
• Intervention / Treatment: Behavioral: Mindfulness Meditation; Behavioral: History of Osteopathy

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Audio-Guided Mindfulness Intervention; Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation.	Behavioral: Mindfulness 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.
ACTIVE_COMPARATOR: History of Osteopathy; Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation.	Behavioral: History of Osteopathy; The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2019
• Primary Completion (ACTUAL): September 16, 2019
• Study Completion (ACTUAL): June 23, 2020

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00116896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be made available to qualified applicants upon receipt of worthy project proposal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No