NCT02590029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

October 26, 2015

Last Update Submit

March 4, 2020

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Use of opioid analgesics

    24 hours prior to and following intervention

  • Anxiety (numeric rating scale)

    Immediately prior to and following intervention

  • Relaxation (numeric rating scale)

    Immediately prior to and following intervention

  • Desire for opioids (numeric rating scale)

    Immediately prior to and following intervention

  • Positive body sensations (numeric rating scale)

    Immediately prior to and following intervention

  • +1 more secondary outcomes

Study Arms (3)

Mindfulness

EXPERIMENTAL

15 minute mindfulness session

Behavioral: Mindfulness

Suggestion

EXPERIMENTAL

15 minute therapeutic suggestion session

Behavioral: Suggestion

Psychoeducation

ACTIVE COMPARATOR

15 minute psychoeducation session

Behavioral: Psychoeducation

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness
SuggestionBEHAVIORAL

The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.

Suggestion
PsychoeducationBEHAVIORAL

The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    PMID: 28702870DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

MindfulnessSuggestion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesHypnosisMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Eric L Garland, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 28, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)