Pragmatic Research eXamining Inpatient Symptoms

NCT01988194 | Completed DMC

• 1 other identifier: 13-11353
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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. 1.decreased pain severity
2. 2.higher patient satisfaction

Conditions

Postoperative Pain; Nausea; Vomiting; Anxiety; Depression

Keywords

acupuncture; postoperative pain; nausea; vomiting; anxiety; depression; hospitalization; inpatient

Outcome Measures

Primary Outcomes (1)

• Self-reported pain

  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.

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcomes (6)

• Self-reported nausea and vomiting

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• Self-reported anxiety and depression

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• 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

• 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

• Self-reported global well-being

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

Other Outcomes (6)

• Hospital costs and charges

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• Use of medications

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• Time to ambulation

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (2)

Usual care

NO INTERVENTION

Participants will receive usual care in the hospital.

Usual care with acupuncture

EXPERIMENTAL

Participants will receive usual care with acupuncture treatments up to four days per week for the duration of their hospital stay.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

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.

Usual care with acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

Related Publications (9)

• Dix P, Sandhar B, Murdoch J, MacIntyre PA. Pain on medical wards in a district general hospital. Br J Anaesth. 2004 Feb;92(2):235-7. doi: 10.1093/bja/aeh052.

  PMID: 14722175 BACKGROUND

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

• Conway Morris A, Howie N. Pain in medical inpatients: an under-recognised problem? J R Coll Physicians Edinb. 2009 Dec;39(4):292-5. doi: 10.4997/JRCPE.2009.401.

  PMID: 21152463 BACKGROUND

• Whelan CT, Jin L, Meltzer D. Pain and satisfaction with pain control in hospitalized medical patients: no such thing as low risk. Arch Intern Med. 2004 Jan 26;164(2):175-80. doi: 10.1001/archinte.164.2.175.

  PMID: 14744841 BACKGROUND

• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.

  PMID: 18443635 BACKGROUND

• Sun Y, Gan TJ, Dubose JW, Habib AS. Acupuncture and related techniques for postoperative pain: a systematic review of randomized controlled trials. Br J Anaesth. 2008 Aug;101(2):151-60. doi: 10.1093/bja/aen146. Epub 2008 Jun 2.

  PMID: 18522936 BACKGROUND

• Ezzo JM, Richardson MA, Vickers A, Allen C, Dibble SL, Issell BF, Lao L, Pearl M, Ramirez G, Roscoe J, Shen J, Shivnan JC, Streitberger K, Treish I, Zhang G. Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002285. doi: 10.1002/14651858.CD002285.pub2.

  PMID: 16625560 BACKGROUND

• Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.

  PMID: 19370583 BACKGROUND

• Chao MT, Chang A, Reddy S, Harrison JD, Acquah J, Toveg M, Santana T, Hecht FM. Adjunctive acupuncture for pain and symptom management in the inpatient setting: protocol for a pilot hybrid effectiveness-implementation study. J Integr Med. 2016 May;14(3):228-38. doi: 10.1016/S2095-4964(16)60252-2.

  PMID: 27181130 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Nausea; Vomiting; Anxiety Disorders; Depression

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Maria T Chao, DrPH, MPA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 20, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

US (1)