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Pragmatic Research eXamining Inpatient Symptoms (PRAXIS)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Vomiting
Postoperative Pain
Nausea
Depression
Anxiety

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01988194
13-11353

Details and patient eligibility

About

Many hospitalized patients experience pain during their hospital stay, and less than half report adequate pain relief. Common treatments for pain include opioid medications, which have associated side effects and complications. Research has shown that acupuncture is effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More research is needed on the effectiveness of adding acupuncture to routine care for hospitalized patients. The objective of this study is to examine the effectiveness of acupuncture delivered in a "real-world" setting according to the principles of traditional Chinese medicine among hospitalized patients to manage pain and other symptoms. 250 hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual care or 2) usual care with acupuncture offered (125 in each group). The primary outcome measure will be change in daily pain intensity. Data on other symptoms, such as nausea, vomiting, anxiety, and depression, as well as functionality and quality of life will be collected in person, on a web-based survey, or via telephone follow-up. The aims of the study are to examine the effectiveness of acupuncture to manage pain and other symptoms among hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a subset of hospitalized patients.

The investigators hypothesize that compared to hospitalized patients receiving usual care alone, hospitalized patients receiving acupuncture will have:

  1. decreased pain severity
  2. higher patient satisfaction

Enrollment

238 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • English or Spanish speaking
  • Admitted to Mt Zion Hospital for a minimum anticipated length of stay for at least 4 days
  • Aged 18 or older
  • In a ward included in the roll out of the Osher Center's acupuncture program at Mt Zion

Exclusion criteria

  • Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction, severe depression, patients in the intensive care unit)
  • Acupuncture contraindication (e.g., sepsis, endocarditis)
  • Inability to consent or complete surveys (e.g., cognitive or communication impairment)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

238 participants in 2 patient groups

Usual care
No Intervention group
Description:
Participants will receive usual care in the hospital.
Usual care with acupuncture
Experimental group
Description:
Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.
Treatment:
Procedure: Acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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