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Psychosocial Support for Pre-operative Pain and Distress (Mind-Body JRA)

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ClinicalTrials.gov Identifier: NCT03665727
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Garland, University of Utah

Brief Summary:
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professions to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, therapeutic suggestion, and psychoeducation for pre-operative patients .

Condition or disease Intervention/treatment Phase
Acute Pain Behavioral: Mindfulness Behavioral: Suggestion Behavioral: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Clinical assessors will be masked at postoperative follow-up
Primary Purpose: Treatment
Official Title: Psychosocial Support for Pre-operative Pain and Distress
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : June 4, 2020
Estimated Study Completion Date : August 4, 2020

Arm Intervention/treatment
Experimental: Mindfulness
15 minute mindfulness session
Behavioral: Mindfulness
The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.

Experimental: Suggestion
15 minute therapeutic suggestion session
Behavioral: Suggestion
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.

Active Comparator: Psychoeducation
15 minute psychoeducation session
Behavioral: Psychoeducation
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.




Primary Outcome Measures :
  1. Pain Intensity Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

  2. Pain Unpleasantness Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.


Secondary Outcome Measures :
  1. Pain Medication Desire Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.

  2. Anxiety Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.

  3. Nondual Awareness Dimensional Assessment - State [ Time Frame: Immediately prior to and following intervention ]
    Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondaul awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bilss and 10 representing complete bliss.

  4. Decentering Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing complete decentering.

  5. Present Moment Awareness Numeric Rating Scale [ Time Frame: Immediately prior to and following intervention ]
    Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present moment and 10 representing complete awareness of the present moment.

  6. Sensation Manikin Body Sensation Report [ Time Frame: Immediately prior to and following intervention ]
    The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores range from .002 to 469, with larger values representing more pleasant sensations reported relative to unpleasant sensations.

  7. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 [ Time Frame: Over the course of post-surgical hospital say, approximately once a day for two days; and, at first outpatient follow-up appointment typically occurring within 1-2 weeks after surgery. ]

    The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale.

    T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking males or females
  • 18 years old or older
  • patients within the University of Utah Hospital system
  • patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

  • Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665727


Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Adam W Hanley, PhD    850-508-0286    adam.hanley@utah.edu   
Sponsors and Collaborators
University of Utah

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Responsible Party: Eric Garland, Associate Dean for Research College of Social Work Director; Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah
ClinicalTrials.gov Identifier: NCT03665727     History of Changes
Other Study ID Numbers: IRB_00085446
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms