Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-31 @ 5:54 AM
Study NCT ID:
NCT06332495
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.', 'timeFrame': 'Four assessments in 48 hours', 'description': 'Pain will be assessed using a numerical pain scale (EN). The caregiver will ask the patient to rate his or her pain between 0 (no pain) and 10 (the most intense pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3', 'timeFrame': '48 hours'}, {'measure': 'Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.', 'timeFrame': '48 hours', 'description': 'Pain will be assessed using a numerical pain scale (EN). The caregiver will ask the patient to rate his or her pain between 0 (no pain) and 10 (the most intense pain imaginable).'}, {'measure': 'Assess patient discomfort on the bedpan', 'timeFrame': '48 hours', 'description': 'discomfort will be defined by the addition of a cushion, rolled towel, treatment oil or the need for the bedpan to be repositioned'}, {'measure': 'Assess alteration of skin condition at the seat of the patient using the bedpan', 'timeFrame': '48 hours', 'description': "Appearance of stage I redness or pressure sores (redness that does not disappear) on the patient's seat, after using the bedpan"}, {'measure': "Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.", 'timeFrame': '48 hours', 'description': 'Pain will be assessed using a numerical pain scale (EN). The caregiver will rate his or her pain between 0 (no pain) and 10 (the most intense pain imaginable).'}, {'measure': 'Assess the risk factors associated with the onset of pain when placing a bedpan.', 'timeFrame': '48 hours'}, {'measure': 'Assess the difficulty of positioning and removing the bedpan.', 'timeFrame': '48 hours', 'description': 'Painfulness of placing and removing the bedpan, assessed by the caregiver using a Likert scale between 1 (easy) and 5 (impossible alone)'}, {'measure': 'Assess bedpan stability during use', 'timeFrame': '48 hours', 'description': 'Stability will be evaluated by the tilting, or not, of the bedpan during use by the patient.'}, {'measure': 'Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort', 'timeFrame': '48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bedpan', 'Discomfort', 'Alteration of Skin', 'Pain'], 'conditions': ['Nurse-Patient Relations']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.\n\nThe objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study.', 'detailedDescription': 'Patients with reduced or severely reduced mobility, over 18 years of age, bedridden and requiring the use of a bedpan, estimated hospitalization equal to or greater than 2 days on the ward.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with reduced or severely reduced mobility, over 18 years of age, bedridden and requiring the use of a bedpan, estimated hospitalization equal to or greater than 2 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of legal age (age ≥ 18 years).\n* Patient with reduced and very reduced mobility, bedridden requiring the use of a bedpan.\n* Estimated length of hospital stay on the ward ≥ 2 days.\n* Patient affiliated to a social security system.\n* Patient able to understand the protocol.\n* Patient having given oral non-opposition to participate.\n* Patient who has received the study information note.\n* Patient who had never participated in this study.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.\n* Patients under guardianship, curatorship or safeguard of justice.'}, 'identificationModule': {'nctId': 'NCT06332495', 'acronym': 'RIDAECUBA', 'briefTitle': 'Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers', 'orgStudyIdInfo': {'id': 'RC23_0573'}, 'secondaryIdInfos': [{'id': '2024-A00025-42', 'type': 'OTHER', 'domain': 'ANSM (IDRCB)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Assessment of pain during pelvic positioning', 'description': '48-hour follow-up of patients included in the study, with data collected on two pelvis fittings per 24 hours of follow-up (one fitting = one installation and one removal).', 'interventionNames': ['Other: Questioning the patient during hygiene care']}], 'interventions': [{'name': 'Questioning the patient during hygiene care', 'type': 'OTHER', 'description': "The study examines how patients and caregivers feel when using the bedpan. Over the course of a day, collecting all this information would take just under 7 minutes. Over the duration of patient participation (2 days), we estimate that it would take a total of 15 minutes per patient to collect this information. The objectives are focused on pain and discomfort, and on the alteration of the (patient's) skin condition through objective observation of redness or stage I pressure sores by the caregiver.", 'armGroupLabels': ['Assessment of pain during pelvic positioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pia SECHER-CAILLETEAU', 'role': 'CONTACT', 'email': 'pia.secher@chu-nantes.fr'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Cholet', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie NOURISSON', 'role': 'CONTACT', 'email': 'stephanie.nourisson@ch-cholet.fr', 'phone': '(+33) 2 41 49 69 85'}], 'facility': 'CHU Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'Laval', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ROMAIN CHAMPAGNE', 'role': 'CONTACT', 'email': 'Romain.CHAMPAGNE@chlaval.fr', 'phone': '(+33) 672091548'}], 'facility': 'CHU Laval', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle Lecompte', 'role': 'CONTACT', 'email': 'gsicot@ch-lemans.fr', 'phone': '(+33) 681220543'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume FOSSAT', 'role': 'CONTACT', 'email': 'guillaume.fossat@chu-orleans.fr', 'phone': '(+33) 2 38.65.13.18'}], 'facility': 'CHU Orleans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'centralContacts': [{'name': 'Jules Galy', 'role': 'CONTACT', 'email': 'jules.galy@chu-nantes.fr', 'phone': '(+33) 253482835'}, {'name': 'Thomas RULLEAU, PhD', 'role': 'CONTACT', 'email': 'Thomas.rulleau@chu-nantes.fr'}], 'overallOfficials': [{'name': 'Pia SECHER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}