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

NCT ID: NCT04477278

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-06-23

Brief Summary

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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

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Conditions

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Pain Satisfaction, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Audio-Guided Mindfulness Intervention

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

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

History of Osteopathy

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

History of Osteopathy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38757714 (View on PubMed)

Other Identifiers

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IRB_00116896

Identifier Type: -

Identifier Source: org_study_id

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