Psychosocial Support for Pre-operative Pain and Distress
Mind-Body JRA
1 other identifier
interventional
727
1 country
1
Brief Summary
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2018
CompletedFirst Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2019
CompletedMay 27, 2020
May 1, 2020
1.3 years
June 12, 2018
May 23, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pain Intensity Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Immediately prior to and following intervention
Pain Unpleasantness Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Immediately prior to and following intervention
Secondary Outcomes (5)
Pain Medication Desire Numeric Rating Scale
Immediately prior to and following intervention
Anxiety Numeric Rating Scale
Immediately prior to and following intervention
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
Nondual Awareness Dimensional Assessment - State
Immediately prior to and following intervention
Sensation Manikin Body Sensation Report
Immediately prior to and following intervention
Other Outcomes (2)
Present Moment Awareness Numeric Rating Scale (Manipulation Check)
Immediately prior to and following intervention
Decentering Numeric Rating Scale (Manipulation Check)
Immediately prior to and following intervention
Study Arms (4)
Mindfulness
EXPERIMENTAL15 minute mindfulness session
Suggestion
EXPERIMENTAL15 minute therapeutic suggestion session
Psychoeducation
ACTIVE COMPARATOR15 minute psychoeducation session
Usual Care
NO INTERVENTIONThe usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy.
Interventions
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.
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
Eligibility Criteria
You may qualify if:
- English-speaking males or females
- 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
You may not qualify if:
- Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.
PMID: 34165999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Clinical assessors were masked at postoperative follow-up
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Dean for Research College of Social Work Director; Center on Mindfulness and Integrative Health Intervention Development (C-MIIND)
Study Record Dates
First Submitted
June 12, 2018
First Posted
September 11, 2018
Study Start
June 4, 2018
Primary Completion
September 23, 2019
Study Completion
September 23, 2019
Last Updated
May 27, 2020
Record last verified: 2020-05