Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 10:19 AM
Study NCT ID:
NCT05902234
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'emotional bodymaps', 'timeFrame': '10months', 'description': 'sensations of emotion in ones body'}], 'secondaryOutcomes': [{'measure': 'pain PROMIS', 'timeFrame': '10 months', 'description': 'pain interference and intensity'}, {'measure': 'psychological flexibility', 'timeFrame': '10 months', 'description': 'measure of psychological flexibility'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Pain']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies. We are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric pain clinic patients and their parents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluency in finnish language\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05902234', 'acronym': 'PedPainEmot', 'briefTitle': 'Emotional Bodymaps in Pediatric Pain Patients and Their Parents.', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Emotional Bodymaps in Pediatric Pain Patients and Their Parents.', 'orgStudyIdInfo': {'id': 'HUS/1301/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric pain patients and their parents', 'description': 'patients and their parents', 'interventionNames': ['Behavioral: interdiciplinary treatment']}], 'interventions': [{'name': 'interdiciplinary treatment', 'type': 'BEHAVIORAL', 'description': 'Normal interdiciplinary treatment path', 'armGroupLabels': ['Pediatric pain patients and their parents']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Reetta M Sipilä, PhD', 'role': 'CONTACT', 'email': 'reetta.sipila@hus.fi', 'phone': '+358406812427'}], 'facility': 'New Childrens Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Reetta M Sipilä, PhD', 'role': 'CONTACT', 'email': 'reetta.sipila@hus.fi', 'phone': '+358407272353'}], 'overallOfficials': [{'name': 'Reetta M Sipilä, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUS, HY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Reetta Sipilä', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}