Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-01 @ 2:30 PM
Study NCT ID:
NCT06836193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Do Emotions Affect Mechanical Pain Thresholds in Individuals with Chronic Pain?
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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure pain thresholds will be measured in kPa', 'timeFrame': 'The measurement takes place at the intervention session. First a baseline measurement is conducted, then comes the intervention and then the intervention measurement takes place.', 'description': 'Pressure pain thresholds will be measured in kPa using a handheld algometer (Somedic AB).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pressure Pain Threshold', 'Pain', 'Emotion'], 'conditions': ['PRESSURE PAIN THRESHOLD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds in individuals with chronic pain.', 'detailedDescription': 'Participants will be randomized into 4 different groups watching different short video-clips (2.20 min). The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video about how to paint a house, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clips.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Above 18 years of age\n* Fluent in Swedish\n* Persistent chronic pain with duration \\> 6 months Exclusion criteria\n* Known neurological disease'}, 'identificationModule': {'nctId': 'NCT06836193', 'briefTitle': 'Do Emotions Affect Mechanical Pain Thresholds in Individuals with Chronic Pain?', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'Do Emotions and Pain Combined Affect Mechanical Pain Thresholds and Other Pain-related Variables in Individuals with Chronic Pain', 'orgStudyIdInfo': {'id': 'Dnr 2024-07781-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Negative emotional condition', 'description': 'The participant will watch a short video-clip with negative emotional content.', 'interventionNames': ['Other: Emotional intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Positive emotional condition', 'description': 'The participant will watch a short video-clip with positive emotional content.', 'interventionNames': ['Other: Emotional intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Neutral emotional condition', 'description': 'The participant will watch a short video-clip with neutral emotional content.', 'interventionNames': ['Other: Emotional intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'No emotional condition', 'description': 'The participant will wait for 2.30 minutes without any instructions about how to engage their thoughts.', 'interventionNames': ['Other: Emotional intervention']}], 'interventions': [{'name': 'Emotional intervention', 'type': 'OTHER', 'description': 'Negative emotional intervention', 'armGroupLabels': ['Negative emotional condition', 'Neutral emotional condition']}, {'name': 'Emotional intervention', 'type': 'OTHER', 'description': 'Positive emotional intervention', 'armGroupLabels': ['No emotional condition', 'Positive emotional condition']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Helena Gunnarsson, Dr', 'role': 'CONTACT', 'email': 'helena.gunnarsson@lnu.se', 'phone': '+46708432509'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linnaeus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Helena Gunnarsson', 'investigatorAffiliation': 'Linnaeus University'}}}}