Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT03802032
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Analgesia for Pain Relief in Hysterosalpingography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042973', 'term': 'K-Y jelly'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'witthin 45 minutes of the procedure', 'description': 'The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10.\n\n0 = absence of pain.\n\n1. = discomfort\n2. = mild pain.\n3. = annoying pain.\n4. = nagging pain.\n5. = distressing pain.\n6. = miserable.\n7. = intense\n8. = Dreadful.\n9. = worse possible\n10. = unbearable'}], 'secondaryOutcomes': [{'measure': 'Patients Satisfaction with procedure', 'timeFrame': 'witthin 45 minutes of the procedure', 'description': 'Satisfaction with the procedure based on Likert scale. The scale is from 1 to 5.\n\n1. = Very dissatisfied.\n2. = Dissatisfied..\n3. = Neither satisfied nor dissatisfied.\n4. = Satisfied.\n5. = Very satisfied.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility', 'hysterosalpingography', 'pain'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The study will involve giving topical analgesia or placebo and then assessing pain and satisfaction during and after the procedure in order to see wed to the placebo.hether the topical analgesia has helped in decreasing pain associated with the procedure and also whether it has increasedd satisfaction with the procedure compar', 'detailedDescription': 'STUDY DESIGN:\n\nThe study will be a double blind randomized controlled trial. Group A:The study group will be given topical Xylocaine (2% Lidocaine) before the procedure.\n\nGroup B:The control group will be given topical K-Y jelly (water based lubricant) before the procedure.\n\nThe participants and the radiologist will be blinded at the point of drug administration.\n\nSAMPLE SIZE DETERMINATION:\n\nThe formula below was used to calculate the sample size n= (Zα + Zβ)2S2 d2\n\nAssuming a difference in mean pain score among groups of 1.5 and using a standard deviation of of 3.15.\n\nZα = standard normal deviate. Zβ = power = 95% = 1.64. S = standard deviation = 3.1. D = mean difference in pain score = 1.5 n = (1.96 + 1.64)2 x 3.12 1.52\n\nn = 55 Sample size per group will be rounded up to 60\n\nSAMPLING APPROACH:\n\nA probability sampling method will be used. Simple random sampling using a computer generated table of random numbers will be used. The WINPEPI version 11.65 software will generate the table of random numbers. The numbers 001-140 will be randomly allocated to two groups A and B. Group A will be the study group and group B will be the control group (see appendix). Each number from the table of random numbers will be copied on separate paper and then sealed in a brown envelope. The envelopes will then be kept inside a box after shuffling.\n\nEach patient will be allocated to the group that the number she picks corresponds to on the computer printout. The numbers were made up to 140 to make up for patients that may eventually drop out from the study.\n\n.\n\nSAMPLING RECRUITEMENT:\n\nWomen that fulfil the inclusion criteria will be recruited from radiology department as they present for Hysterosalpingogram. After obtaining a written consent, participants will be requested to pick one of the brown envelopes which will contain the randomization group.\n\nBLINDING The drugs to be used (K-Y Jelly and Xylocaine gel) are identical.\n\nDATA COLLECTION METHOD:\n\nAn informed written consent will be obtained from participants. Psychological support will be given to the participant by a nurse after the procedure has been explained to the participant. A questionnaire will then be filled. The participant will then be requested to pick an envelope that represents the study number. A detailed explanation about the VAS and its application was given personally to each woman before the procedure. An interviewer administered questionnaire will be used to obtain information on socio-demographic characteristics, reproductive profile, previous history of the procedure and experience with analgesia.\n\nThe analgesic or placebo will be applied to the cervix (15ml) using a vaginal applicator 10 minutes before the procedure.\n\nThe procedure will then be done using standard clinical protocol. The pain rating scale will be used to evaluate pain during from zero (no pain) to ten (worst possible pain) will be explained to the client. The visual scale comparison to happy, glum, sad and horrified faces will also be explained to the patient.\n\nPain assessment will be done during the procedure at the following steps:\n\n1. After application of speculum.\n2. After cervical manipulation (application of tenaculum and catheter).\n3. After filling the uterus with contrast medium.\n4. After withdrawal of speculum and catheter.\n5. Thirty minutes after completing the procedure.\n\nThe Likert scale will be used to assess patient satisfaction following pain management.\n\n.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'based on biological gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.\n\nExclusion Criteria:\n\n* Women that present for hysterosalpingography for other indications apart from infertility and those that have history of allergy to xylocaine and/or K-Y jelly.'}, 'identificationModule': {'nctId': 'NCT03802032', 'acronym': 'HSG', 'briefTitle': 'Topical Analgesia for Pain Relief in Hysterosalpingography', 'organization': {'class': 'OTHER', 'fullName': 'Ahmadu Bello University Teaching Hospital'}, 'officialTitle': 'Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'Ahmadu Bello University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': '15g of Topical Xylocaine gel', 'interventionNames': ['Drug: Lidocaine Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '15g of KY Jelly', 'interventionNames': ['Drug: KY jelly']}], 'interventions': [{'name': 'Lidocaine Gel', 'type': 'DRUG', 'description': 'topical lidocaine gel', 'armGroupLabels': ['Study Group']}, {'name': 'KY jelly', 'type': 'DRUG', 'description': 'topical KY jelly', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PMB 06', 'city': 'Zaria', 'state': 'Kaduna State', 'country': 'Nigeria', 'facility': 'Ahmadu Bello University Teaching Hospital Shika-Zaria', 'geoPoint': {'lat': 11.11128, 'lon': 7.7227}}], 'overallOfficials': [{'name': 'Anisah Yahya, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ahmadu Bello University Zaria'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'within 6 months of completion', 'ipdSharing': 'YES', 'description': 'obtained data and result will be shared', 'accessCriteria': 'free'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmadu Bello University Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Anisah Yahya', 'investigatorAffiliation': 'Ahmadu Bello University Teaching Hospital'}}}}