Nurse-Patient RelationsRIDAECUBANCT06332495
Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
An observational study of Nurse-Patient Relations, run by Nantes University Hospital at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- Questioning the patient during hygiene care
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Aug 2024to 3 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.
- Patients under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas RULLEAU, PhD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Cholet
Cholet
Stéphanie NOURISSON, (+33) 2 41 49 69 85, stephanie.nourisson@ch-cholet.fr
- Recruiting
CHU Laval
Laval
ROMAIN CHAMPAGNE, (+33) 672091548, Romain.CHAMPAGNE@chlaval.fr
- Recruiting
CH Le Mans
Le Mans
Emmanuelle Lecompte, (+33) 681220543, gsicot@ch-lemans.fr
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44093
Pia SECHER-CAILLETEAU, pia.secher@chu-nantes.fr
- Recruiting
CHU Orleans
Orléans
Guillaume FOSSAT, (+33) 2 38.65.13.18, guillaume.fossat@chu-orleans.fr
About this study
Official title: Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
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.
Read the 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.
- Conditions
- Nurse-Patient Relations
- Being tested
- Questioning the patient during hygiene care
- Keywords
- Bedpan, Discomfort, Alteration of Skin, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questioning the patient during hygiene careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questioning the patient during hygiene care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 48 hours
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).
Measured: 48 hours
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
Measured: 48 hours
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
Measured: 48 hours
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).
Measured: 48 hours
Assess the risk factors associated with the onset of pain when placing a bedpan.
Measured: 48 hours
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)
Measured: 48 hours
Assess bedpan stability during use
Stability will be evaluated by the tilting, or not, of the bedpan during use by the patient.
Measured: 48 hours
Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start3 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion3 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pia SECHER, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332495
- Sponsor's protocol ID
- RC23_0573
- Other IDs
- 2024-A00025-42
- Acronym
- RIDAECUBA
- Status last verified
- May 2025
- First submitted
- 13 Mar 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
- ClinicalTrials.gov ID
- NCT06332495
- Acronym / sponsor ID
- RIDAECUBA / RC23_0573
- Conditions
- Nurse-Patient Relations
- Keywords
- Bedpan, Discomfort, Alteration of Skin, Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of pain during pelvic positioning | – | Other: Questioning the patient during hygiene care48-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.
- Patients under guardianship, curatorship or safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questioning the patient during hygiene careThe 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. | Other | Assessment of pain during pelvic positioning |
Primary outcome
Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.
Time frame: Four assessments in 48 hours
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).
9 secondary outcomes
Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3
Time frame: 48 hours
Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.
Time frame: 48 hours
Assess patient discomfort on the bedpan
Time frame: 48 hours
Assess alteration of skin condition at the seat of the patient using the bedpan
Time frame: 48 hours
Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.
Time frame: 48 hours
Assess the risk factors associated with the onset of pain when placing a bedpan.
Time frame: 48 hours
Assess the difficulty of positioning and removing the bedpan.
Time frame: 48 hours
Assess bedpan stability during use
Time frame: 48 hours
Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas RULLEAU, PhD contact
Pia SECHER principal investigator
Nantes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse-Patient Relations, run by Nantes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jules Galy ((+33) 253482835, jules.galy@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. (time frame: Four assessments in 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.