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Gender, Pain, and Placebo Analgesia

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ClinicalTrials.gov Identifier: NCT00314392
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : February 6, 2008
Sponsor:
Collaborators:
The Research Council of Norway
University of Tromso
Information provided by:
University Hospital of North Norway

Brief Summary:
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 or disease Intervention/treatment
Experimental Pain Behavioral: Information (behavior)

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia
Study Start Date : September 2006
Study Completion Date : December 2007



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

Secondary Outcome Measures :
  1. Subjective arousal


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 years, healthy

Exclusion Criteria:

  • pregnant, earlier serious disease or injury,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314392


Locations
Norway
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

ClinicalTrials.gov Identifier: NCT00314392     History of Changes
Other Study ID Numbers: Placebo
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: February 6, 2008
Last Verified: February 2008

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