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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06332495
Acronym
RIDAECUBA
Enrollment
300
Registered
2024-03-27
Start date
2024-08-03
Completion date
2026-08-03
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nurse-Patient Relations

Keywords

Bedpan, Discomfort, Alteration of Skin, Pain

Brief summary

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

OTHERQuestioning 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.Four assessments in 48 hoursPain 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).

Secondary

MeasureTime frameDescription
Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.348 hours
Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.48 hoursPain 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).
Assess patient discomfort on the bedpan48 hoursdiscomfort will be defined by the addition of a cushion, rolled towel, treatment oil or the need for the bedpan to be repositioned
Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.48 hoursPain 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).
Assess alteration of skin condition at the seat of the patient using the bedpan48 hoursAppearance of stage I redness or pressure sores (redness that does not disappear) on the patient's seat, after using the bedpan
Assess the difficulty of positioning and removing the bedpan.48 hoursPainfulness of placing and removing the bedpan, assessed by the caregiver using a Likert scale between 1 (easy) and 5 (impossible alone)
Assess bedpan stability during use48 hoursStability will be evaluated by the tilting, or not, of the bedpan during use by the patient.
Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort48 hours
Assess the risk factors associated with the onset of pain when placing a bedpan.48 hours

Countries

France

Contacts

Primary ContactJules Galy
jules.galy@chu-nantes.fr(+33) 253482835
Backup ContactThomas RULLEAU, PhD
Thomas.rulleau@chu-nantes.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026