Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-21 @ 11:32 PM
Study NCT ID:
NCT06611267
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experiences of Pain in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experienced pain measured on a Visual Analogue Scale (VAS) from 0-10 (from no pain to worst imaginable pain) without cream compared to experienced pain measured on a Visual Analogue Scale (VAS) from 0-10 (from no pain to worst imaginable pain) with cream', 'timeFrame': 'From beginning to end of experiment, approx. 45 minutes'}], 'secondaryOutcomes': [{'measure': 'The effect of assessing expected pain intensity measured on a Visual Analogue Scale (VAS) from 0-10 (from no expected pain to worst imaginable expected pain)', 'timeFrame': 'From beginning to end of experiment, approx. 45 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy adults', 'Pain', 'Experience of pain'], 'conditions': ['Pain in Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The experiment aims to investigate the experience of pain in healthy adults and includes a total of 60 participants. Pain is a subjective experience that has a complicated neurological and psychological basis. Around 20% of the Danish population suffers from persistent pain, which has both personal and societal consequences. Personal consequences include, among others, reduced quality of life, loss of social life and risk of anxiety and depression. However, more knowledge is needed about which mechanisms are involved in the experience of pain, so that the treatment of patients with pain can be improved.\n\nIn the experiment, healthy participants will be inflicted with a tolerable pain on their forearm using a thermode. The application of heat causes pain for a short, limited period, but it is tolerable and without risks. During the experiment, the participants will be exposed to heat several times, with and without a cream on their forearm. It is a cream that has previously proved to have pain-relieving effects on participants in similar experiments. Participants will be asked about how they experience the intensity of the pain on a scale of 1-10 (0 = no pain and 10 = worst imaginable pain), and what they expect the pain intensity will be, also on a 1-10 scale. The participants are allowed to pause or stop the experiment anytime.\n\nThe experiment contributes to insights into pain and the mechanisms involved. This knowledge can in the future contribute with knowledge to improve the treatment of patients with pain. For the individual participant, the trial will contribute with knowledge about how they experience and assess pain themselves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal health, i.e. no known acute or chronic illness\n* Fluid in Danish\n\nExclusion Criteria:\n\n* Chronic pain condition\n* Other medical or psychiatric disorder\n* Use of antidepressants\n* Daily use of painkillers\n* Use of pain medication 24 hours prior to testing\n* Drug abuse\n* Pregnancy\n* Studying or with completed education in psychology or journalism'}, 'identificationModule': {'nctId': 'NCT06611267', 'briefTitle': 'Experiences of Pain in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'En undersøgelse af Smerteoplevelsen Hos Raske forsøgsdeltagere (A Study of the Pain Experience in Healthy Participants)', 'orgStudyIdInfo': {'id': 'EXPERIENCES OF PAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants assess their experienced pain', 'interventionNames': ['Other: Pain without cream on', 'Other: Pain with cream on']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants assess their expected and experienced pain', 'interventionNames': ['Other: Pain without cream on', 'Other: Pain with cream on']}], 'interventions': [{'name': 'Pain without cream on', 'type': 'OTHER', 'description': 'Participants will be inflicted with pain without cream on.', 'armGroupLabels': ['Participants assess their expected and experienced pain', 'Participants assess their experienced pain']}, {'name': 'Pain with cream on', 'type': 'OTHER', 'description': 'Patients are inflicted with pain after getting a cream on, which has previously had pain-relieving effects', 'armGroupLabels': ['Participants assess their expected and experienced pain', 'Participants assess their experienced pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}