<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01733771</url>
  </required_header>
  <id_info>
    <org_study_id>BNZ-0041-09</org_study_id>
    <nct_id>NCT01733771</nct_id>
  </id_info>
  <brief_title>The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients</brief_title>
  <official_title>Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bnai Zion Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bnai Zion Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of complementary medicine (CAM) treatments on patient&#xD;
      reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such&#xD;
      as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators&#xD;
      compare outcomes between two groups: Standard of care (treatments that are provided commonly&#xD;
      in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both&#xD;
      quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea,&#xD;
      wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Symptomatic patients are referred to CAM treatments by the medical staff of the departments.&#xD;
      Patients interested in CAM treatments may receive various CAM treatments such as reflexology,&#xD;
      acupuncture, guided imagery and hypnosis, according to patient preference and practitioner&#xD;
      availability. Patients are requested to grade the severity of their symptoms on a visual&#xD;
      analogue scale (0-100) before treatment and within 3 hours following treatments. Patients who&#xD;
      are interested in standard care alone and not interested in CAM treatments grade their&#xD;
      symptoms similarly, and serve as a control group. Primary outcomes are symptomatic relief and&#xD;
      secondary outcomes are correlations between belief or disbelief in CAM with the primary&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2010</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic</measure>
    <time_frame>within 4 hours following treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlations between expectations from CAM as measured on a likert scale (0= disbelief and 5- high belief)and primary outcomes</measure>
    <time_frame>at baseline evaluation (time 0')</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Pain</condition>
  <condition>Nausea</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>CAM with standard care</arm_group_label>
    <description>Symptomatic hospitalized people referred by the medical team to CAM treatments on top of standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care only</arm_group_label>
    <description>Symptomatic patients who are referred to CAM treatments but are not interested in such treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAM treatments</intervention_name>
    <description>CAM treatments last 10-30 minutes</description>
    <arm_group_label>CAM with standard care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All hospitalized patients who can consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ELAD SCHIFF, PI</last_name>
    <email>ESCHIFF@BEZEQINT.NET</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ELAD SCHIFF</last_name>
      <email>ESCHIFF@BEZEQINT.NET</email>
    </contact>
    <investigator>
      <last_name>ELAD SCHIFF, PI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>January 13, 2016</last_update_submitted>
  <last_update_submitted_qc>January 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>complementary medicine</keyword>
  <keyword>hospitalized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733771
org study id: BNZ-0041-09
nct id: NCT01733771
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic
time frame: within 4 hours following treatment
measure: 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')
arm group label: CAM with standard care
description: Symptomatic hospitalized people referred by the medical team to CAM treatments on top of standard of care
arm group label: Standard care only
description: Symptomatic patients who are referred to CAM treatments but are not interested in such treatments
intervention type: Other
intervention name: CAM treatments
description: CAM treatments last 10-30 minutes
arm group label: CAM with standard care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ELAD SCHIFF, PI
email: ESCHIFF@BEZEQINT.NET
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Nausea