Overview

This trial is active, not recruiting.

Conditions postoperative pain, nausea, vomiting, anxiety, depression
Treatment acupuncture
Sponsor University of California, San Francisco
Start date November 2013
End date December 2014
Trial size 250 participants
Trial identifier NCT01988194, 13-11353

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Participants will receive usual care in the hospital.
(Experimental)
Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.
acupuncture
Acupuncture treatments will be provided in patient rooms up to four days per week for the duration of their hospital stay. Treatments will be consistent with how acupuncture is typically practiced: acupuncturists will diagnosis patients according to principles of traditional Chinese medicine (TCM); and treatments will be individualized to the patients. Duration of assessment, needle placement and retention will be 20-30 minutes.

Primary Outcomes

Measure
Self-reported pain
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcomes

Measure
Self-reported nausea and vomiting
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Self-reported anxiety and depression
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Functionality and quality of life
time frame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days
Patient satisfaction
time frame: Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days
Self-reported global well-being
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Self-reported global rating of change
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients
Principal investigator Maria T Chao, DrPH, MPA
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.