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Completed

NCT Number: NCT03665727

Psychosocial Support for Pre-operative Pain and Distress

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

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.

Suggestion

Behavioral

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

Psychoeducation

Behavioral

The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

Primary outcomes

  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 outcomes

  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. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0

    Time frame: 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.

  4. 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 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.

  5. 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 below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.

Other outcomes

  1. Present Moment Awareness Numeric Rating Scale (Manipulation Check)

    Time frame: Immediately prior to and following intervention

    Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present and 10 representing complete awareness of the present moment.

  2. Decentering Numeric Rating Scale (Manipulation Check)

    Time frame: Immediately prior to and following intervention

    Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: Mind-Body JRA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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