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ClinicalTrials.gov ID

NCT06332495

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

May 31, 2025Actual

Start Date

Aug 3, 2024Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 3, 2026Estimated

Official Title

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

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.

• Nurse-Patient Relations

• Questioning the patient during hygiene care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Nantes University HospitalOTHER

stephanie.nourisson@ch-cholet.fr(+33) 2 41 49 69 85

Romain.CHAMPAGNE@chlaval.fr(+33) 672091548

gsicot@ch-lemans.fr(+33) 681220543

guillaume.fossat@chu-orleans.fr(+33) 2 38.65.13.18