Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02570659
Status:
UNKNOWN
Last Update Posted:
2017-11-20
First Post:
2015-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014911', 'term': 'Whiplash Injuries'}], 'ancestors': [{'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '6 months', 'description': 'Self reported pain the last three days (NRS)'}], 'secondaryOutcomes': [{'measure': 'Whiplash Disability Questionnaire (WDQ)', 'timeFrame': '6 months'}, {'measure': 'SF-12', 'timeFrame': '6 months', 'description': 'Health related quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['WAD', 'Whiplash', 'Information Video'], 'conditions': ['Whiplash Syndrome']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).', 'detailedDescription': 'Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, \\<18\\<65 years of age and low knowledge of the Swedish language.\n\nA randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.\n\nThe patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.\n\nThe follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.\n\nThe primary outcome is level of pain (NRS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knowledge of the swedish language\n* Traffic injury with neck pain\n\nExclusion Criteria:\n\n* Fractures\n* In house care needed'}, 'identificationModule': {'nctId': 'NCT02570659', 'briefTitle': 'Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating the Effect of an Information Video in a Acute Whiplash Population', 'orgStudyIdInfo': {'id': 'Erics Whiplash RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Information Folder', 'description': 'A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual)'}, {'type': 'EXPERIMENTAL', 'label': 'Information Video', 'description': 'A multiprofessional information video', 'interventionNames': ['Behavioral: Information Video']}], 'interventions': [{'name': 'Information Video', 'type': 'BEHAVIORAL', 'description': 'A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise', 'armGroupLabels': ['Information Video']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Eric Rydman', 'role': 'CONTACT', 'phone': '+46704331436'}], 'facility': 'Eric Rydman', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Med dr', 'investigatorFullName': 'Eric Rydman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}