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

May 30, 2025 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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 caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.
Time Frame: Four assessments in 48 hours
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).
Four assessments in 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3
Time Frame: 48 hours
48 hours
Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.
Time Frame: 48 hours
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).
48 hours
Assess patient discomfort on the bedpan
Time Frame: 48 hours
discomfort will be defined by the addition of a cushion, rolled towel, treatment oil or the need for the bedpan to be repositioned
48 hours
Assess alteration of skin condition at the seat of the patient using the bedpan
Time Frame: 48 hours
Appearance of stage I redness or pressure sores (redness that does not disappear) on the patient's seat, after using the bedpan
48 hours
Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.
Time Frame: 48 hours
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).
48 hours
Assess the risk factors associated with the onset of pain when placing a bedpan.
Time Frame: 48 hours
48 hours
Assess the difficulty of positioning and removing the bedpan.
Time Frame: 48 hours
Painfulness of placing and removing the bedpan, assessed by the caregiver using a Likert scale between 1 (easy) and 5 (impossible alone)
48 hours
Assess bedpan stability during use
Time Frame: 48 hours
Stability will be evaluated by the tilting, or not, of the bedpan during use by the patient.
48 hours
Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Pia SECHER, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 3, 2026

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC23_0573
  • 2024-A00025-42 (Other Identifier: ANSM (IDRCB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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