Gender, Pain, and Placebo Analgesia
| Tracking Information | |||||
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| First Received Date ICMJE | April 11, 2006 | ||||
| Last Updated Date | February 4, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Pain report, heart rate variability, skin conductance | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00314392 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Subjective arousal | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gender, Pain, and Placebo Analgesia | ||||
| Official Title ICMJE | Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Experimental Pain | ||||
| Intervention ICMJE | Behavioral: Information (behavior) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 74 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00314392 | ||||
| Other Study ID Numbers ICMJE | Placebo | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital of North Norway | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital of North Norway | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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