Psychosocial Support for Acute Hospital Pain and Distress

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT02590029
Collaborator
(none)
244
1
3
35
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness
  • Behavioral: Suggestion
  • Behavioral: Psychoeducation
N/A

Study Design

Study Type:
Interventional
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 :
Nov 1, 2015
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity (numeric rating scale) [Immediately prior to and following intervention]

    0-10 scale

  2. Pain unpleasantness (numeric rating scale) [Immediately prior to and following intervention]

    0-10 scale

Secondary Outcome Measures

  1. Use of opioid analgesics [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) [Immediately prior to and following intervention]

    0-10 scale

  3. Relaxation (numeric rating scale) [Immediately prior to and following intervention]

    0-10 scale

  4. Desire for opioids (numeric rating scale) [Immediately prior to and following intervention]

    0-10 scale

  5. Positive body sensations (numeric rating scale) [Immediately prior to and following intervention]

    0-10 scale

  6. Use of non-opioid analgesics (NSAID) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah Hospital Salt Lake City Utah United States 84112

Sponsors and Collaborators

  • University of Utah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eric Garland, Associate Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT02590029
Other Study ID Numbers:
  • 00085446
First Posted:
Oct 28, 2015
Last Update Posted:
Mar 6, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2020