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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Bnai Zion Medical Center
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01733771
First received: July 10, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention
Pain
Nausea
Anxiety
Other: CAM treatments

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic [ Time Frame: within 4 hours following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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') ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Complementary medicine in addition to standard of 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 of care only
Symptomatic patients who are referred to CAM treatments but are not interested in such 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733771

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

Locations
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

No publications provided

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01733771     History of Changes
Other Study ID Numbers: BNZ-0041-09
Study First Received: July 10, 2012
Last Updated: November 27, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Bnai Zion Medical Center:
complementary medicine
hospitalized

ClinicalTrials.gov processed this record on September 16, 2014