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

NCT ID: NCT06332495

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-03

Study Completion Date

2026-08-03

Brief Summary

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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

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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.

Conditions

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Nurse-Patient Relations

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Questioning the patient during hygiene care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pia SECHER

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, Loire Atlantique, France

Site Status RECRUITING

CHU Cholet

Cholet, , France

Site Status RECRUITING

CHU Laval

Laval, , France

Site Status RECRUITING

CH Le Mans

Le Mans, , France

Site Status RECRUITING

CHU Orleans

Orléans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jules Galy

Role: CONTACT

(+33) 253482835

Thomas RULLEAU, PhD

Role: CONTACT

Facility Contacts

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Pia SECHER-CAILLETEAU

Role: primary

Stéphanie NOURISSON

Role: primary

(+33) 2 41 49 69 85

ROMAIN CHAMPAGNE

Role: primary

(+33) 672091548

Emmanuelle Lecompte

Role: primary

(+33) 681220543

Guillaume FOSSAT

Role: primary

(+33) 2 38.65.13.18

Other Identifiers

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2024-A00025-42

Identifier Type: OTHER

Identifier Source: secondary_id

RC23_0573

Identifier Type: -

Identifier Source: org_study_id

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