Psychosocial Support for Pre-operative Pain and Distress

Acute Pain Clinical Trial

— Mind-Body JRA  

Official title:

Psychosocial Support for Pre-operative Pain and Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665727
• Other study ID #: IRB_00085446
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: September 23, 2019

Study information

• Verified date: May 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 727
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.
• Suggestion
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
• Psychoeducation
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Present Moment Awareness Numeric Rating Scale (Manipulation Check)	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.	Immediately prior to and following intervention
Other	Decentering Numeric Rating Scale (Manipulation Check)	Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.	Immediately prior to and following intervention
Primary	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
Primary	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	Pain Medication Desire Numeric Rating Scale	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.	Immediately prior to and following intervention
Secondary	Anxiety Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.	Immediately prior to and following intervention
Secondary	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	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.	During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
Secondary	Nondual Awareness Dimensional Assessment - State	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.	Immediately prior to and following intervention
Secondary	Sensation Manikin Body Sensation Report	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.	Immediately prior to and following intervention