Psychosocial Support for Acute Hospital Pain and Distress

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Behavioral: Mindfulness; Behavioral: Suggestion; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Pain unpleasantness (numeric rating scale)	0-10 scale	Immediately prior to and following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours prior to and following intervention
Anxiety (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Relaxation (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Desire for opioids (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Positive body sensations (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
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.	Within 24 hours prior to and following intervention

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Eric L Garland, PhD, University of Utah

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 00085446