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Psychosocial Support for Acute Hospital Pain and Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02590029
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : March 6, 2020
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 social workers to patients reporting uncontrolled pain during a hospital stay. This study will examine the differential effects of brief mindfulness training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled pain.

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)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial Support for Acute Hospital Pain and Distress
Actual Study Start Date : November 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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 ]
    0-10 scale

  2. Pain unpleasantness (numeric rating scale) [ Time Frame: Immediately prior to and following intervention ]
    0-10 scale


Secondary Outcome Measures :
  1. Use of opioid analgesics [ Time Frame: 24 hours prior to and following intervention ]
    The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention. Opioid dose will be standardized and calculated using conventional morphine daily equivalent equianalgesic conversion tables.

  2. Anxiety (numeric rating scale) [ Time Frame: Immediately prior to and following intervention ]
    0-10 scale

  3. Relaxation (numeric rating scale) [ Time Frame: Immediately prior to and following intervention ]
    0-10 scale

  4. Desire for opioids (numeric rating scale) [ Time Frame: Immediately prior to and following intervention ]
    0-10 scale

  5. Positive body sensations (numeric rating scale) [ Time Frame: Immediately prior to and following intervention ]
    0-10 scale

  6. Use of non-opioid analgesics (NSAID) [ Time Frame: Within 24 hours prior to and following intervention ]
    The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention. NSAID dose will be standardized and calculated using conventional NSAID equianalgesic conversion tables.



Information from the National Library of Medicine

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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 or older within the University of Utah Hospital system reporting "intolerable pain" or "inadequate pain control" on the Clinically Aligned Pain Assessment Tool (CAPA; Donaldson & Chapman, 2013).

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): NCT02590029


Locations
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United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Eric L Garland, PhD University of Utah
Publications:
Donaldson, G., & Chapman, C.R. (2013). Pain management is more than just a number. University of Utah Health/Department of Anesthesiology. Salt Lake City, Utah: Department of Anesthesiology.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Garland, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02590029    
Other Study ID Numbers: 00085446
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations