Psychosocial Support for Pre-operative Pain and Distress

Not Applicable

Completed

• Conditions: Acute Pain
• Interventions: Behavioral: Suggestion; Behavioral: Psychoeducation; Behavioral: Mindfulness

• Registration Number: NCT03665727
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-23
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 727

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suggestion	Suggestion	15 minute therapeutic suggestion session
Psychoeducation	Psychoeducation	15 minute psychoeducation session
Mindfulness	Mindfulness	15 minute mindfulness session

Primary Outcome Measures

Name	Time	Method
Pain Unpleasantness Numeric Rating Scale	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.
Pain Intensity Numeric Rating Scale	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.

Secondary Outcome Measures

Name	Time	Method
Sensation Manikin Body Sensation Report	Immediately prior to and following intervention	The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
Pain Medication Desire Numeric Rating Scale	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.
Anxiety Numeric Rating Scale	Immediately prior to and following intervention	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
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.	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.
Nondual Awareness Dimensional Assessment - State	Immediately prior to and following intervention	Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual 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 bliss and 10 representing complete bliss.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States