Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-02 @ 2:45 AM
Study NCT ID:
NCT05908292
Status:
UNKNOWN
Last Update Posted:
2023-12-13
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Participant Recruitment', 'timeFrame': '1 year', 'description': 'To evaluate the rate of participant recruitment, the investigators will calculate how many participants were recruited on average per month per hospital site.'}, {'measure': 'Rate of Participant Attrition', 'timeFrame': '1 year', 'description': 'To evaluate the rate of participant attrition, the investigators will calculate the number of participants that drop out of the study over the total number of participants that are randomized in the study over the study period.'}, {'measure': 'Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data', 'timeFrame': '1 year', 'description': 'To evaluate the response rate and the completeness of the PFDI-20 the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the PFDI-20.'}, {'measure': 'Number of The Carol Scale with missing data', 'timeFrame': '1 year', 'description': 'To evaluate the response rate and the completeness of the Carol Scale the investigators will track how many questionnaires are not completed and determine if there is any missing data in the responses to the Carol Scale.'}, {'measure': 'Number of participants to complete self-scar massage protocol as intended', 'timeFrame': '1 year', 'description': "To evaluate the acceptability of the self-scar massage intervention, the investigators will examine participants' reported intervention frequency and time of intervention on their records and note any deviation from the intervention protocol. Some participant interviews will be conducted from a program evaluation lens to determine how the intervention was received. Exemplar quotes will be used to describe participants experience of the self-scar massage intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perineal Tear', 'Vaginal Tear', 'Episiotomy'], 'conditions': ['Episiotomy; Complications', 'Scar Tissue', 'Perineal Tear', 'Vaginal Tear Resulting From Childbirth']}, 'descriptionModule': {'briefSummary': 'The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible.\n\nThe main questions it aims to answer are:\n\nCan the investigators recruit 130 participants and aim for 80% retention of participants in this study?\n\nAre the response rates to questionnaires and completeness of questionnaires acceptable?\n\nDo the participants find the self-scar tissue massage intervention easy and acceptable to perform and do they adhere to the protocol?\n\nType of Study: Clinical Trial\n\nParticipant Population/Health Conditions: The participant population will be 18 years of age or older, primiparous, within 1 year postpartum after vaginal delivery with healed episiotomy and/or vaginal perineal tear(s) as confirmed to them by their maternity care provider or family doctor at their 6 week postpartum check or other appointment. The participants will also need to have sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.\n\nInvestigators will compare the scores on two reliable and validated pelvic health questionnaires in those in the intervention and control groups. The intervention group will be provided an instructional video on self-scar tissue massage and asked to perform self-scar massage and record their intervention and experience over a 6-week period. The control group will receive routine postnatal care (no self-scar massage training or performance). Patient medical records will be used to collect demographic data and labour and delivery characteristics. Two reliable and validated pelvic health questionnaires will be used for outcome measures. Baseline outcomes will be performed at the start of the study and then repeated 6 weeks later and again 18 weeks later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Primiparous\n* Within 1 year postpartum after vaginal delivery with episiotomy and/or vaginal/perineal tear\n* Healed episiotomy and/or vagina/perineal tear as confirmed to them by their maternity care provider or family doctor at their postpartum check or other appointment\n* Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.\n\nExclusion Criteria:\n\n* Self-reported current vaginal infection or urinary tract infection\n* Self-reported gynecological surgery after delivery'}, 'identificationModule': {'nctId': 'NCT05908292', 'acronym': 'EPIS', 'briefTitle': 'Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue The EPIS Trial: A Pilot Randomized Control Trial to Determine Feasibility', 'orgStudyIdInfo': {'id': 'REB23-0097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Episiotomy and Vaginal/Perineal Tear Self-Scar Massage', 'description': 'This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue.', 'interventionNames': ['Procedure: Pelvic Floor Scar Tissue Self-Scar Massage']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Postnatal Care', 'description': 'This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.'}], 'interventions': [{'name': 'Pelvic Floor Scar Tissue Self-Scar Massage', 'type': 'PROCEDURE', 'description': 'Self scar-massage intervention of healed pelvic floor scar tissue for 5 minutes, 3x/week for 6 weeks.', 'armGroupLabels': ['Episiotomy and Vaginal/Perineal Tear Self-Scar Massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Gina-Marie Cerantola, BSc, DPT', 'role': 'CONTACT', 'email': 'ginamarie.cerantola@ucalgary.ca', 'phone': '403-606-0953'}, {'name': 'Gina-Marie Cerantola, BSc, DPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erin Brennand, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Gina-Marie Cerantola, BSc, DPT', 'role': 'CONTACT', 'email': 'ginamarie.cerantola@ucalgary.ca', 'phone': '403-606-0953'}], 'overallOfficials': [{'name': 'Erin Brennand, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Health services', 'class': 'OTHER'}, {'name': 'Alberta Innovates Health Solutions', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}