NCT04477278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 13, 2020

Last Update Submit

July 15, 2020

Conditions

PainSatisfaction, Patient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Arms (2)

Audio-Guided Mindfulness Intervention

EXPERIMENTAL

Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation.

Behavioral: Mindfulness Meditation

History of Osteopathy

ACTIVE COMPARATOR

Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation.

Behavioral: History of Osteopathy

Interventions

Mindfulness MeditationBEHAVIORAL

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.

Audio-Guided Mindfulness Intervention
History of OsteopathyBEHAVIORAL

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

History of Osteopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for OMT at the Huntsman Cancer Institute

You may not qualify if:

  • Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Hanley AW, Wilson Zingg R, Smith B, Zappa M, White S, Davis A, Worts PR, Culjat C, Martorella G. Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials. J Integr Complement Med. 2024 Nov;30(11):1082-1091. doi: 10.1089/jicm.2024.0020. Epub 2024 May 17.

    PMID: 38757714DERIVED

MeSH Terms

Conditions

PainPatient Satisfaction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 20, 2020

Study Start

March 25, 2019

Primary Completion

September 16, 2019

Study Completion

June 23, 2020

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations

US(1)