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

NCT06332495 | Recruiting

• 2 other identifiers: RC23_05732024-A00025-42
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Nurse-Patient Relations

Keywords

Bedpan; Discomfort; Alteration of Skin; Pain

Outcome Measures

Primary Outcomes (1)

• Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.

  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 Outcomes (9)

• Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3

  48 hours

• Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.

  48 hours

• Assess patient discomfort on the bedpan

  48 hours

• Assess alteration of skin condition at the seat of the patient using the bedpan

  48 hours

• Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.

  48 hours

Study Arms (1)

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

Interventions

Questioning the patient during hygiene care 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.

Assessment of pain during pelvic positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (5)

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

RECRUITING

CHU Cholet

Cholet, France

RECRUITING

CHU Laval

Laval, France

RECRUITING

CH Le Mans

Le Mans, France

RECRUITING

CHU Orleans

Orléans, France

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pia SECHER

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jules Galy

CONTACT

(+33) 253482835; jules.galy@chu-nantes.fr

Thomas RULLEAU, PhD

CONTACT

Thomas.rulleau@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 27, 2024
• Study Start: August 3, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)