Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:04 AM
Study NCT ID:
NCT07437235
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device.', 'timeFrame': 'Day 1', 'description': 'The primary evaluation criterion is the pain experienced at each stage of IUD insertion. This will be assessed using a numerical pain scale from 0 to 10 during the insertion of the speculum, Pozzi forceps, and intrauterine device, by the patient immediately after insertion. Pain 5 minutes after insertion is also assessed using the same method.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the criteria motivating the choice of intrauterine device contraception in multiparous patients.', 'timeFrame': '1 day', 'description': 'The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.'}, {'measure': 'Evaluate the criteria motivating the choice of intrauterine device contraception in nulliparous patients.', 'timeFrame': '1 day', 'description': 'The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.'}, {'measure': 'Assessing the stress generated by the insertion of an intrauterine device', 'timeFrame': '1 day', 'description': 'The patient\'s anxiety level will be assessed before the procedure using the Spielberger State Anxiety Scale. This self-administered questionnaire comprises 20 items. It uses a 4-point Likert scale to evaluate the intensity of the subject\'s feelings ("no," "somewhat no," "somewhat yes," "yes"). Each response to an item is scored from 1 to 4, with 1 indicating the lowest level of anxiety and 4 the highest. The score is calculated by summing the scores obtained for each item. The score can therefore range from 20 to 80.'}, {'measure': 'Evaluation of the rate of continued use at 6 months, then at 1 year during follow-up', 'timeFrame': '12 months', 'description': 'The satisfaction rate will be assessed by a telephone questionnaire at 6 and 12 months, allowing for an evaluation of the continuation rate. This involves measuring the percentage of women who are still using the contraceptive system at 6 and 12 months.'}, {'measure': 'Evaluation of the side effects caused by this method of contraception during follow-up.', 'timeFrame': '12 months', 'description': "les potentiels effets secondaires engendrés par ce mode de contraception comme l'aménorrhée, la survenue de spotting, de céphalées, ou encore de mastodynie seront évalués par un questionnaire téléphonique à 6 mois et 12mois"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain assessment', 'nulliparous/multiparous parity'], 'conditions': ['Intrauterine Contraceptive Device Complication']}, 'descriptionModule': {'briefSummary': 'The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action.\n\nOne of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion.\n\nThere is little data in the literature on the pain experienced by patients, and even less in relation to their parity.\n\nSeveral studies have been conducted and show that nulliparous women seemed to experience more intense pain compared to multiparous women (2.7 vs 1.9 p\\<0.05)', 'detailedDescription': 'The hypotheses of this study are:\n\n* Pain is more intense in nulliparous women than in multiparous women.\n* Nulliparous women are more anxious before IUD insertion than multiparous women.\n* Satisfaction rates at 6 and 12 months do not differ according to parity.\n\nPain will be assessed at each stage of IUD insertion using a numerical pain scale from 0 to 10 for speculum insertion, Pozzi forceps insertion, and IUD insertion, by the patient herself. Pain will be reassessed 5 minutes after insertion, also by the patient.\n\nPatients\' anxiety levels will be assessed before insertion using the Spielberger State Anxiety Scale. This is a self-administered questionnaire comprising 20 items. This is a 4-point Likert scale assessing the intensity of the subject\'s feelings ("no," "somewhat no," "somewhat yes," "yes").\n\nThe satisfaction rate will be assessed by telephone questionnaire at 6 and 12 months, allowing us to evaluate the continuation rate as well as potential side effects of this method of contraception, such as amenorrhea, spotting, headaches, or mastalgia.\n\nBased on the results, the aim of this study is to propose appropriate pain management and information to reduce any anxiety and reassure patients about their satisfaction with this method of contraception.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'nulliparous and multiparous women who accept the insertion of an intrauterine device', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 or older\n* Patients desiring intrauterine device (IUD) contraception.\n* Patients without contraindications to the desired IUD contraception (uterine malformation, pregnancy, undiagnosed vaginal bleeding, current STI, Wilson's disease, uterine cancer, uterine fibroids, current phlebitis, breast cancer, hormone-sensitive condition, etc.).\n* Patients agreeing to participate in the study.\n* Patients agreeing to be contacted at 6 months and 1 year.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients 25 years of age or younger who have not been screened for Chlamydia and Gonorrhea prior to IUD insertion.\n* Patients with a contraindication to IUD insertion.\n* Patients with risk factors for sexually transmitted infections.\n* Patients with comprehension difficulties and/or a language barrier.\n* Patients who object to participating in the study.\n* Intrauterine device insertion by a practitioner in training (first insertion)."}, 'identificationModule': {'nctId': 'NCT07437235', 'acronym': 'DODIU', 'briefTitle': 'A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'A Regional, Multicenter Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women According to Their Parity', 'orgStudyIdInfo': {'id': '2021/091/OB'}, 'secondaryIdInfos': [{'id': '2021-A010232-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nulliparous patients at the time of insertion of an intrauterine contraceptive system', 'description': "The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects."}, {'label': 'Multiparous patients at the time of insertion of an intrauterine contraceptive system', 'description': "The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects."}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'University Rouen Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Isabelle IM MOTTE, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service de Gynécologie-Obstétrique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}