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Psychosocial Support for Acute Hospital Pain and Distress

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Suggestion
Psychoeducation
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mindfulness

Suggestion

Psychoeducation

Arm Description

15 minute mindfulness session

15 minute therapeutic suggestion session

15 minute psychoeducation session

Outcomes

Primary Outcome Measures

Pain intensity (numeric rating scale)
0-10 scale
Pain unpleasantness (numeric rating scale)
0-10 scale

Secondary Outcome Measures

Use of opioid analgesics
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.
Anxiety (numeric rating scale)
0-10 scale
Relaxation (numeric rating scale)
0-10 scale
Desire for opioids (numeric rating scale)
0-10 scale
Positive body sensations (numeric rating scale)
0-10 scale
Use of non-opioid analgesics (NSAID)
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.

Full Information

First Posted
October 26, 2015
Last Updated
March 4, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT02590029
Brief Title
Psychosocial Support for Acute Hospital Pain and Distress
Official Title
Psychosocial Support for Acute Hospital Pain and Distress
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
15 minute mindfulness session
Arm Title
Suggestion
Arm Type
Experimental
Arm Description
15 minute therapeutic suggestion session
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
15 minute psychoeducation session
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Suggestion
Intervention Description
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
Primary Outcome Measure Information:
Title
Pain intensity (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Title
Pain unpleasantness (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Secondary Outcome Measure Information:
Title
Use of opioid analgesics
Description
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.
Time Frame
24 hours prior to and following intervention
Title
Anxiety (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Title
Relaxation (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Title
Desire for opioids (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Title
Positive body sensations (numeric rating scale)
Description
0-10 scale
Time Frame
Immediately prior to and following intervention
Title
Use of non-opioid analgesics (NSAID)
Description
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.
Time Frame
Within 24 hours prior to and following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Garland, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
28702870
Citation
Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
Results Reference
derived

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Psychosocial Support for Acute Hospital Pain and Distress

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