Gender, Pain, and Placebo Analgesia

February 4, 2008 updated by: University Hospital of North Norway

Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

74

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

  • Norway
    • Troms
      • Tromsø, Troms, Norway, N-9038
        • University Hospital of North Norway

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40 years, healthy

Exclusion Criteria:

  • pregnant, earlier serious disease or injury,

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain report, heart rate variability, skin conductance

Secondary Outcome Measures

Outcome Measure
Subjective arousal

Collaborators and Investigators

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

Sponsor

University Hospital of North Norway

Collaborators

University of Tromso
The Research Council of Norway

Investigators

  • Principal Investigator: Magne Arve Flaten, PhD, University of Tromso

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

September 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 4, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Placebo

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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