Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-29 @ 11:23 PM
Study NCT ID:
NCT07278804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Pain Control Options Menu for IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Will initially enroll a control group that does not receive any intervention, after control group data is complete, will enroll for the intervention group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified PCCC Autonomy Score', 'timeFrame': 'Day of study enrollment/IUD insertion', 'description': 'A modified version of the Person-Centered Contraceptive Care (PCCC) scale will be used to measure patient autonomy. This scale is a 4-item questionnaire evaluating provider performance regarding respect for patients, information provision, and eliciting and honoring patient preferences for birth control. The total score will be a number between 4 and 20.'}], 'secondaryOutcomes': [{'measure': 'Highest level of pain experienced', 'timeFrame': 'Day of IUD insertion procedure, 24 hours after IUD insertion procedure', 'description': 'Patients will be asked to rate the highest level of pain that they experienced during IUD insertion/during the 24 hours after IUD insertion on a scale from 0-10.'}, {'measure': 'Number of participants in which pain felt met expectations', 'timeFrame': 'Day of IUD insertion procedure, 24 hours after IUD insertion procedure', 'description': 'Patients will be asked whether the pain they experienced was less than, the same as, or more pain than they expected.'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'Day of IUD insertion procedure, 24 hours after IUD insertion procedure', 'description': "Patient's will be asked to rate their overall satisfaction with their IUD insertion experience on a scale from 0-10."}, {'measure': 'Number of participants who would choose an IUD for contraception again', 'timeFrame': 'Day of IUD insertion procedure, 24 hours after IUD insertion procedure', 'description': 'Patient will be asked whether they would choose an IUD for contraception again based on their IUD insertion experience. Answer options will be yes or no.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IUD insertion', 'Pain control options menu', 'Pain control'], 'conditions': ['IUD Insertion Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate if using a pain management options menu for IUD (intrauterine device) insertion improves patient autonomy, satisfaction, and/or pain. The main questions it aims to answer are:\n\nDoes a pain management options menu for IUD insertion improve patient autonomy? Does a pain management options menu for IUD insertion improve patient satisfaction? Does a pain management options menu for IUD insertion improve patient pain?\n\nResearchers will compare survey data from patients receiving IUDs before and after a pain management options menu is implemented.\n\nParticipants will be asked to answer survey questions addressing their feelings of autonomy, satisfaction, and pain in regards to their IUD insertion experience.', 'detailedDescription': 'The investigators are developing a pain management options menu to be given to patients who are undergoing IUD insertion with the goal of improving patient autonomy, satisfaction, and pain scores. The investigators will give patients a survey exploring these aspects of the IUD insertion experience and compare the survey results from patients who were surveyed before the menu was implemented and after the menu was implemented.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having an IUD placed in a clinic visit\n* Able to read and speak English\n* Age 18-50 years old\n\nExclusion Criteria:\n\n* Having an IUD placed in the operating room under general anesthesia'}, 'identificationModule': {'nctId': 'NCT07278804', 'briefTitle': 'Development of a Pain Control Options Menu for IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Development of a Pain Control Options Menu for IUD Insertion', 'orgStudyIdInfo': {'id': 'Pro00117230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No menu - control group', 'description': 'Control group - no intervention administered'}, {'type': 'EXPERIMENTAL', 'label': 'Menu - intervention group', 'description': 'Participants will receive the pain control options menu prior to IUD insertion', 'interventionNames': ['Other: Pain control options menu']}], 'interventions': [{'name': 'Pain control options menu', 'type': 'OTHER', 'description': 'A menu of pain control options available to participants to choose from during IUD (intrauterine device) insertion procedure', 'armGroupLabels': ['Menu - intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Emile Gleeson, MD', 'role': 'CONTACT', 'email': 'eig9@duke.edu', 'phone': '206-369-3035'}, {'name': 'Elizabeth Thomason, MD, MPH', 'role': 'CONTACT', 'email': 'elizabeth.i.deans@duke.edu', 'phone': '984-209-8734'}, {'name': 'Elizabeth Thomason, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emile Gleeson, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Emile Gleeson, MD', 'role': 'CONTACT', 'email': 'eig9@duke.edu', 'phone': '206-369-3035'}, {'name': 'Elizabeth Thomason, MD, MPH', 'role': 'CONTACT', 'email': 'elizabeth.i.deans@duke.edu', 'phone': '984-209-8734'}], 'overallOfficials': [{'name': 'Elizabeth Thomason, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}