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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477278
• Other study ID #: IRB_00116896
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: July 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 23, 2020
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Satisfaction, Patient

Intervention

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.
• History of Osteopathy
The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)