Anxiety, Depression, Nausea, Postoperative Pain, Vomiting
Conditions
Keywords
acupuncture, postoperative pain, nausea, vomiting, anxiety, depression, hospitalization, inpatient
Brief 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
Interventions
PROCEDUREAcupuncture
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pain | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Daily pain intensity will be measured on a 0-10 numeric rating scale. The APS Patient Outcome Questionnaire will also be administered each day to measure pain severity and relief; impact of pain on activity, sleep, and negative emotions; side effects of treatment; helpfulness of information about pain treatment; and ability to participate in pain treatment decisions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported nausea and vomiting | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Daily nausea and vomiting symptoms will be measured using the 2-question Postoperative Nausea and Vomiting Scale. |
| Self-reported anxiety and depression | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Every other day, anxiety and depression will be measured using the 30-item Profile of Mood States questionnaire. |
| Functionality and quality of life | Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days | Functionality and quality of life will be measured using the EQ-5D questionnaire at baseline and within 3 days of hospital discharge. |
| Patient satisfaction | Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days | Within 3 days after hospital discharge, participants will be contacted to answer questions about their recent hospital stay, including questions about communication with clinicians, responsiveness of hospital staff, cleanliness and quietness of the hospital environment, pain management, and overall experience in the hospital. |
| Self-reported global well-being | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Every other day, global well-being will be measured using the single item Arizona Integrated Outcomes Scale. |
| Self-reported global rating of change | Participants will be followed for the duration of hospital stay, an expected average of 6 days | On the last day of hospitalization, the patient's minimal clinically important difference in pain will be measured using the single item Patient Global Impression of Change Scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of medications | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Data about medication use will be extracted from the participant's medical chart, including type(s) of analgesics, total dose, the number of agents, whether opioids and/or adjuncts were required, and mode of delivery. |
| Time to ambulation | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Data will be extracted from the participant's medical chart to determine date of ambulation. |
| 30 day readmission | Participants will be followed for the duration of hospital stay and for up to 30 days after hospital discharge, for a total expected average of 36 days | Data will be extracted from the participant's medical chart to determine whether the participant has been readmitted to the hospital within 30 days of discharge. |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Data will be extracted from the participant's medical chart to determine length of hospital stay. |
| Foley catheter removal | Participants will be followed for the duration of hospital stay, an expected average of 6 days | Data will be extracted from the participant's medical chart to determine date of Foley catheter removal. |
| Hospital costs and charges | Participants will be followed for the duration of hospital stay, an expected average of 6 days | After discharge from the hospital, data from the medical record will be extracted to determine the diagnosis group, length of stay, and costs of medications used for pain, anxiety, nausea/vomiting, and anesthesia. |
Countries
United States
Outcome results
None listed