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

Pain Clinical Trial

Official title:

Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01733771
• Other study ID #: BNZ-0041-09
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2012
• Last updated: January 13, 2016
• Start date: April 2010
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Bnai Zion Medical Center
• Contact: ELAD SCHIFF, PI
• Email: ESCHIFF[@]BEZEQINT.NET
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All hospitalized patients who can consent

Exclusion Criteria:

• Patients who cannot consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Nausea
• Pain

Intervention

Other:
• CAM treatments
CAM treatments last 10-30 minutes

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic relief expressed in Visual Analogue Scales from asymptomatic 0-100 extremely symptomatic		within 4 hours following treatment	No
Secondary	correlations between expectations from CAM as measured on a likert scale (0= disbelief and 5- high belief)and primary outcomes		at baseline evaluation (time 0')	No