Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

August 9, 2013 updated by: Karin Meissner, Ludwig-Maximilians - University of Munich

Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial

The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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

  • Germany
      • Munich, Germany, 80336
        • Institute of Medical Psychology, Ludwig-Maximilians-University Munich

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 to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • not meeting inclusion criteria
  • hypotension or hypertension
  • treated or untreated hypertension or hypotension
  • Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
  • diseases that influence the cardiovascular or gastrointestinal system
  • intake of drugs affecting blood pressure and/or autonomic nervous system
  • pregnancy and lactation phase
  • body mass index >= 32
  • cardiovascular risk factors (diabetes, smoking)
  • drug or alcohol abuse
  • insufficient compliance
  • participation in another trial within the last three months

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
Active Comparator: Histaminum hydrochloricum globuli
To allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect
Drug: Histaminum hydrochloricum globuli
Experimental: Placebo globuli
Drug: Placebo globuli
placebo globuli administered together with verbal suggestions of a hypotensive drug effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure (systolic, diastolic)
Time Frame: minutes 1 to 30 after intervention
minutes 1 to 30 after intervention

Collaborators and Investigators

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

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Karin Meissner, MD, Ludwig-Maximilians - University of Munich

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.

Helpful Links

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

August 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • KM-DZ-06

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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