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Effect of Complementary and Alternative Medicine on Pain Among Inpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190240
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Allina Health System

Study Description
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Brief Summary:

The proposed study has 3 aims: 1) quantitatively describe a model for delivering complementary and alternative medicine (CAM) therapies to understand the selection of patients and CAM therapies used for pain management, 2) examine the effects of selected CAM therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies on duration of pain change.

Positive results from this study will assist hospitals in the integration of usual care and CAM therapy for pain reduction. Findings may also drive future research on the cost effectiveness of these therapies for pain management, as well as the impact on patient outcomes such as length of stay and use of narcotics.


Condition or disease
Pain

Study Design
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Study Type : Observational
Actual Enrollment : 4422 participants
Observational Model: Case-Only
Official Title: Effect of Complementary and Alternative Medicine on Pain Among Inpatients
Study Start Date : January 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Model of delivering CAM therapies [ Time Frame: Up to 4 years ]
    Quantitatively describe a model for delivering CAM therapies to understand selection of patients and CAM therapies used for pain management.

  2. Effects of selected CAM therapies on immediate change in pain [ Time Frame: CAM Visit (30-45 minutes) ]
    We will examine the effectiveness of CAM therapies on self-reported (11 point scale) pain measured just before and immediately after service delivery.

  3. Effects of selected CAM therapies on duration of pain change. [ Time Frame: 5 hours ]
    We will examine the effectiveness of CAM therapies on repeated measures of self-reported pain over several hours after therapy to assess the distribution and decay of the pain change effect.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Abbott Northwestern Hospital Inpatients
Criteria

Aims 1 and 2 Inclusion Criteria:

  • Admission to Abbott Northwestern Hospital
  • Consent to release of electronic health record for research purposes
  • 18 years of age or older
  • Length of stay greater than 24 hours

Aims 1 and 2 Exclusion Criteria:

  • None

Aim 3 Inclusion Criteria:

  • Admission to Abbott Northwestern Hospital
  • Length of stay greater than 24 hours
  • 18 years of age or older
  • Consent to release of electronic health record for research purposes
  • Received CAM therapy in current hospitalization
  • Pain level of 1 or greater at the pre-treatment assessment by practitioner
  • English-speaking
  • Integrative medicine therapy ended between 9:00 am and 4:00 pm

Aim 3 Exclusion Criteria:

  • Refuses consent
  • Unable to provide consent due to competency concerns
  • Has declined study participation 3 times during current hospitalization
  • Has hard declined during current hospitalization
  • Has been approached 6 times during current hospitalization
  • Has been approached to consent earlier that day
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190240


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Allina Health System
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Jeffery Dusek, PhD Allina Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT02190240    
Other Study ID Numbers: AT006518-01
R01AT006518-01 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Allina Health System:
Complementary and Alternative Medicine
Integrative Medicine
Pain Management