Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers

Официальное название

Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 caregi

Первичные конечные точки

• Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. [Срок оценки: Four assessments in 48 hours]

Вторичные конечные точки (9)

• Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3 [Срок оценки: 48 hours]
• Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan. [Срок оценки: 48 hours]
• Assess patient discomfort on the bedpan [Срок оценки: 48 hours]
• Assess alteration of skin condition at the seat of the patient using the bedpan [Срок оценки: 48 hours]
• Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan. [Срок оценки: 48 hours]
• Assess the risk factors associated with the onset of pain when placing a bedpan. [Срок оценки: 48 hours]
• Assess the difficulty of positioning and removing the bedpan. [Срок оценки: 48 hours]
• Assess bedpan stability during use [Срок оценки: 48 hours]
• Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Patient of legal age (age ≥ 18 years).
• 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.

Критерии исключения

• Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.
• Patients under guardianship, curatorship or safeguard of justice.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 5 центров

• Nantes University Hospital — Nantes
• CHU Cholet — Cholet
• CHU Laval — Laval
• CH Le Mans — Le Mans
• CHU Orleans — Orléans

Идентификаторы

NCT: NCT06332495 · RC23_0573 · 2024-A00025-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗