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The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT01733771
Recruitment Status : Unknown
Verified January 2016 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : November 27, 2012
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center

Study Description
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Brief Summary:
This study evaluates the effects of complementary medicine (CAM) treatments on patient reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators compare outcomes between two groups: Standard of care (treatments that are provided commonly in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea, wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.

Condition or disease Intervention/treatment
Pain Nausea Anxiety Other: CAM treatments

Detailed Description:
Symptomatic patients are referred to CAM treatments by the medical staff of the departments. Patients interested in CAM treatments may receive various CAM treatments such as reflexology, acupuncture, guided imagery and hypnosis, according to patient preference and practitioner availability. Patients are requested to grade the severity of their symptoms on a visual analogue scale (0-100) before treatment and within 3 hours following treatments. Patients who are interested in standard care alone and not interested in CAM treatments grade their symptoms similarly, and serve as a control group. Primary outcomes are symptomatic relief and secondary outcomes are correlations between belief or disbelief in CAM with the primary outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients
Study Start Date : April 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
CAM with standard care
Symptomatic hospitalized people referred by the medical team to CAM treatments on top of standard of care
 Other: CAM treatments
CAM treatments last 10-30 minutes
Standard care only
Symptomatic patients who are referred to CAM treatments but are not interested in such treatments


Outcome Measures
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Primary Outcome Measures :
  1. Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic [ Time Frame: within 4 hours following treatment ]

Secondary Outcome Measures :
  1. correlations between expectations from CAM as measured on a likert scale (0= disbelief and 5- high belief)and primary outcomes [ Time Frame: at baseline evaluation (time 0') ]

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
All hospitalized patients
Criteria

Inclusion Criteria:

  • All hospitalized patients who can consent

Exclusion Criteria:

  • Patients who cannot consent
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): NCT01733771


Contacts
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Contact: ELAD SCHIFF, PI ESCHIFF@BEZEQINT.NET

Locations
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Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: ELAD SCHIFF       ESCHIFF@BEZEQINT.NET   
Principal Investigator: ELAD SCHIFF, PI         
Sponsors and Collaborators
Bnai Zion Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01733771    
Other Study ID Numbers: BNZ-0041-09
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Keywords provided by Bnai Zion Medical Center:
complementary medicine
hospitalized
Additional relevant MeSH terms:
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Nausea
Signs and Symptoms, Digestive