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

Nurse-Patient Relations Clinical Trial

— RIDAECUBA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332495
• Other study ID #: RC23_0573
• Secondary ID: 2024-A00025-42
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 3, 2025

Study information

• Verified date: June 2024
• Source: Nantes University Hospital
• Contact: Jules Galy
• Phone: (+33) 253482835
• Email: bp-prom-regl[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 3, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 had a pelvis placed by the evaluating caregiver prior to inclusion.

• 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.

Related Conditions & MeSH terms

• Nurse-Patient Relations
• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
France	CHU Cholet	Cholet
France	CHU Laval	Laval
France	CH Le Mans	Le Mans
France	Nantes University Hospital	Nantes	Loire Atlantique
France	CHU Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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