Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karin Meissner, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00937196
First received: July 9, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Blood Pressure
Drug: Placebo globuli
Drug: Histaminum hydrochloricum globuli

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Blood pressure (systolic, diastolic) [ Time Frame: minutes 1 to 30 after intervention ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: No treatment

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00937196

Locations
Germany
Institute of Medical Psychology, Ludwig-Maximilians-University Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Karin Meissner, MD Ludwig-Maximilians - University of Munich
  More Information

Additional Information:
No publications provided

Responsible Party: Karin Meissner, PD Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00937196     History of Changes
Other Study ID Numbers: KM-DZ-06
Study First Received: July 9, 2009
Last Updated: August 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on July 28, 2014