Psychosocial Support for Acute Hospital Pain and Distress

Acute Pain Clinical Trial

Official title:

Psychosocial Support for Acute Hospital Pain and Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590029
• Other study ID #: 00085446
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.
• Suggestion
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
• Psychoeducation
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Primary	Pain unpleasantness (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Secondary	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
Secondary	Anxiety (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Secondary	Relaxation (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Secondary	Desire for opioids (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Secondary	Positive body sensations (numeric rating scale)	0-10 scale	Immediately prior to and following intervention
Secondary	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