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

January 13, 2016 updated by: Bnai Zion Medical Center

Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Bnai Zion Medical Center
        • Contact:
        • Principal Investigator:
          • ELAD SCHIFF, PI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All hospitalized patients

Description

Inclusion Criteria:

  • All hospitalized patients who can consent

Exclusion Criteria:

  • Patients who cannot consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic
Time Frame: within 4 hours following treatment
within 4 hours following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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')
at baseline evaluation (time 0')

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNZ-0041-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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