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OpenTrials
Completed

NCT Number: NCT02190240

Effect of Complementary and Alternative Medicine on Pain Among Inpatients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2014
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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