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Recruiting NCT06332495

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

— Observational Nurse-Patient Relations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questioning the patient during hygiene care.
Who it may be relevant to
Registry conditions: Nurse-Patient Relations. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. [Time frame: Four assessments in 48 hours]
Secondary outcome measures (9)
  • Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3 [Time frame: 48 hours]
  • Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan. [Time frame: 48 hours]
  • Assess patient discomfort on the bedpan [Time frame: 48 hours]
  • Assess alteration of skin condition at the seat of the patient using the bedpan [Time frame: 48 hours]
  • Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan. [Time frame: 48 hours]
  • Assess the risk factors associated with the onset of pain when placing a bedpan. [Time frame: 48 hours]
  • Assess the difficulty of positioning and removing the bedpan. [Time frame: 48 hours]
  • Assess bedpan stability during use [Time frame: 48 hours]
  • Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort [Time frame: 48 hours]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 5 centers
  • Nantes University Hospital — Nantes
  • CHU Cholet — Cholet
  • CHU Laval — Laval
  • CH Le Mans — Le Mans
  • CHU Orleans — Orléans

Identifiers

NCT: NCT06332495 · RC23_0573 · 2024-A00025-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗