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Gender, Pain, and Placebo Analgesia
This study has been completed.
Sponsors and Collaborators: University Hospital of North Norway
The Research Council of Norway
University of Tromso
Information provided by: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00314392
  Purpose

The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.


Condition Intervention
Experimental Pain
Behavioral: Information (behavior)

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Pain report, heart rate variability, skin conductance

Secondary Outcome Measures:
  • Subjective arousal

Estimated Enrollment: 74
Study Start Date: September 2006
Study Completion Date: December 2007
Detailed Description:

The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general.

The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 years, healthy

Exclusion Criteria:

  • pregnant, earlier serious disease or injury,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314392

Locations
Norway, Troms
University Hospital of North Norway
Tromsø, Troms, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
The Research Council of Norway
University of Tromso
Investigators
Principal Investigator: Magne Arve Flaten, PhD University of Tromso
  More Information

Study ID Numbers: Placebo
Study First Received: April 11, 2006
Last Updated: February 4, 2008
ClinicalTrials.gov Identifier: NCT00314392  
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
Experimental pain
Placebo analgesia
Heart rate variability
Skin conductance

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 16, 2009