Clinical trial NCT06332495: Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
Official title: Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nurse-Patient Relations
Keywords: Bedpan
Discomfort
Alteration of Skin
Pain
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.
timeFrame: Four assessments in 48 hours
Secondary outcomes:
measure: Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3
timeFrame: 48 hours
measure: Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.
timeFrame: 48 hours
measure: Assess patient discomfort on the bedpan
timeFrame: 48 hours
measure: Assess alteration of skin condition at the seat of the patient using the bedpan
timeFrame: 48 hours
measure: Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.
timeFrame: 48 hours
measure: Assess the risk factors associated with the onset of pain when placing a bedpan.
timeFrame: 48 hours
measure: Assess the difficulty of positioning and removing the bedpan.
timeFrame: 48 hours
measure: Assess bedpan stability during use
timeFrame: 48 hours
measure: Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort
timeFrame: 48 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire Atlantique
city: Cholet
country: France
facility: CHU Cholet
city: Laval
country: France
facility: CHU Laval
city: Le Mans
country: France
facility: CH Le Mans
city: Orléans
country: France
facility: CHU Orleans
Study officials:
affiliation: Nantes University Hospital
name: Pia SECHER
role: PRINCIPAL_INVESTIGATOR
References: