Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04497220
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Poke and a Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Max pain score during the epidural procedure', 'timeFrame': '1 hour', 'description': 'Maximum pain score will be measured using a single 11-point Numeric Rating Scale 0-10, where 0 is no pain and 10 is maximum imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Overall satisfaction during the epidural procedure', 'timeFrame': '1 hour', 'description': 'Overall satisfaction during the epidural procedure will be measured used a 5-point likert scale: 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, 1=very dissatisfied.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural Anesthesia (labor)'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.', 'detailedDescription': 'The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording "Poke and a burn" prior to subcutaneous local anesthetic administration for the epidural placement and one will contain "this is numbing medication, which will make the rest of the procedure go easier". There will be no difference in the epidural placement, medications, or the rest of the script.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnancy\n* requesting an epidural for the first time\n\nExclusion Criteria:\n\n* previous epidural (either for labor or for surgery)\n* BMI greater than 40 kg/m\\^2\n* previous lumbar spine surgery\n* inability to speak English\n* a history of chronic pain or are on chronic opioids\n* a history of opioid drug abuse'}, 'identificationModule': {'nctId': 'NCT04497220', 'briefTitle': 'Poke and a Placebo', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ANES-2020-29006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Nocebo Group', 'description': 'Participants in this group will receive the control treatment', 'interventionNames': ['Behavioral: Negative Connotation Langauge']}, {'type': 'EXPERIMENTAL', 'label': 'Positive Connotation Group', 'description': 'Participants in this group will receive the experimental treatment.', 'interventionNames': ['Behavioral: Positive Connotation Language']}], 'interventions': [{'name': 'Negative Connotation Langauge', 'type': 'BEHAVIORAL', 'description': 'The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The control script includes language containing the wording "Poke and a burn" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.', 'armGroupLabels': ['Nocebo Group']}, {'name': 'Positive Connotation Language', 'type': 'BEHAVIORAL', 'description': 'The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The experimental script includes language containing the wording "this is numbing medication, which will make the rest of the procedure go easier" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.', 'armGroupLabels': ['Positive Connotation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candace Nelson', 'role': 'CONTACT', 'email': 'nelso377@umn.edu', 'phone': '612-626-2465'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Aaron Berg, MD', 'role': 'CONTACT', 'email': 'bergx831@umn.edu', 'phone': '612-624-9990'}, {'name': 'Jonah Pearson, MD', 'role': 'CONTACT', 'email': 'pears731@umn.edu', 'phone': '612-625-6659'}], 'overallOfficials': [{'name': 'Aaron Berg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}