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OpenTrials
Completed

NCT Number: NCT02590029

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Hospital

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

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

Behavioral

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

Psychoeducation

Behavioral

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

Primary outcomes

  1. Pain intensity (numeric rating scale)

    Time frame: Immediately prior to and following intervention

    0-10 scale

  2. Pain unpleasantness (numeric rating scale)

    Time frame: Immediately prior to and following intervention

    0-10 scale

Secondary outcomes

  1. Use of opioid analgesics

    Time frame: 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)

    Time frame: Immediately prior to and following intervention

    0-10 scale

  3. Relaxation (numeric rating scale)

    Time frame: Immediately prior to and following intervention

    0-10 scale

  4. Desire for opioids (numeric rating scale)

    Time frame: Immediately prior to and following intervention

    0-10 scale

  5. Positive body sensations (numeric rating scale)

    Time frame: Immediately prior to and following intervention

    0-10 scale

  6. Use of non-opioid analgesics (NSAID)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2015
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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