protocolSection identificationModule nctId: NCT06332495, orgStudyIdInfo id: RC23_0573, secondaryIdInfos id: 2024-A00025-42, type: OTHER, domain: ANSM (IDRCB), briefTitle: Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers, acronym: RIDAECUBA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, 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.The 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., conditionsModule conditions: Nurse-Patient Relations, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Questioning the patient during hygiene care, outcomesModule primaryOutcomes measure: Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan., secondaryOutcomes measure: Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3, secondaryOutcomes measure: Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan., secondaryOutcomes measure: Assess patient discomfort on the bedpan, secondaryOutcomes measure: Assess alteration of skin condition at the seat of the patient using the bedpan, secondaryOutcomes measure: Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan., secondaryOutcomes measure: Assess the risk factors associated with the onset of pain when placing a bedpan., secondaryOutcomes measure: Assess the difficulty of positioning and removing the bedpan., secondaryOutcomes measure: Assess bedpan stability during use, secondaryOutcomes measure: Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Pia SECHER-CAILLETEAU, role: CONTACT, email: pia.secher@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Cholet, city: Cholet, country: France, contacts name: Nelly DIXNEUF, role: CONTACT, phone: (+33) 2 41 49 69 85, email: nelly.dixneuf@ch-cholet.fr, geoPoint lat: 47.06667, lon: -0.88333, locations facility: CHU Laval, city: Laval, country: France, contacts name: ROMAIN CHAMPAGNE, role: CONTACT, phone: (+33) 672091548, email: Romain.CHAMPAGNE@chlaval.fr, geoPoint lat: 48.06667, lon: -0.76667, locations facility: CH Le Mans, city: Le Mans, country: France, contacts name: Emmanuelle Lecompte, role: CONTACT, phone: (+33) 681220543, email: gsicot@ch-lemans.fr, geoPoint lat: 48.0, lon: 0.2, locations facility: CHU Orleans, city: Orléans, country: France, contacts name: Guillaume FOSSAT, role: CONTACT, phone: (+33) 2 38.65.13.18, email: guillaume.fossat@chu-orleans.fr, geoPoint lat: 47.90289, lon: 1.90389, hasResults: False