Gender, Pain, and Placebo Analgesia

Experimental Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314392
• Other study ID #: Placebo
• Status: Completed
• Phase: N/A
• First received: April 11, 2006
• Last updated: February 4, 2008
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40 years, healthy

Exclusion Criteria:

• pregnant, earlier serious disease or injury,

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Experimental Pain

Intervention

Behavioral:
• Information (behavior)

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	The Research Council of Norway, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain report, heart rate variability, skin conductance
Secondary	Subjective arousal