Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-06-27 @ 12:41 AM
Study NCT ID:
NCT00314392
Status:
COMPLETED
Last Update Posted:
2008-02-06
First Post:
2006-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender, Pain, and Placebo Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-04', 'studyFirstSubmitDate': '2006-04-11', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain report, heart rate variability, skin conductance'}], 'secondaryOutcomes': [{'measure': 'Subjective arousal'}]}, 'conditionsModule': {'keywords': ['Experimental pain', 'Placebo analgesia', 'Heart rate variability', 'Skin conductance'], 'conditions': ['Experimental Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years, healthy\n\nExclusion Criteria:\n\n* pregnant, earlier serious disease or injury,'}, 'identificationModule': {'nctId': 'NCT00314392', 'briefTitle': 'Gender, Pain, and Placebo Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia', 'orgStudyIdInfo': {'id': 'Placebo'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Information (behavior)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-9038', 'city': 'Tromsø', 'state': 'Troms', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Magne Arve Flaten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}, {'name': 'University of Tromso', 'class': 'OTHER'}]}}}