Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
NCT ID: NCT06332495
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-08-03
2026-08-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Assessment of pain during pelvic positioning
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).
Questioning the patient during hygiene care
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.
Interventions
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Questioning the patient during hygiene care
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.
Eligibility Criteria
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Inclusion Criteria
* Patient with reduced and very reduced mobility, bedridden requiring the use of a bedpan.
* Estimated length of hospital stay on the ward ≥ 2 days.
* Patient affiliated to a social security system.
* Patient able to understand the protocol.
* Patient having given oral non-opposition to participate.
* Patient who has received the study information note.
* Patient who had never participated in this study.
Exclusion Criteria
* Patients under guardianship, curatorship or safeguard of justice.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pia SECHER
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, Loire Atlantique, France
CHU Cholet
Cholet, , France
CHU Laval
Laval, , France
CH Le Mans
Le Mans, , France
CHU Orleans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A00025-42
Identifier Type: OTHER
Identifier Source: secondary_id
RC23_0573
Identifier Type: -
Identifier Source: org_study_id
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