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NCT Number: NCT06332495

Research Project on the Risk of Discomfort, Pain, 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.

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Key information

Conditions

Nurse-Patient Relations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital, Nantes, Loire Atlantique, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

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

    Time frame: 48 hours

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

    Time frame: 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).

  3. Assess patient discomfort on the bedpan

    Time frame: 48 hours

    discomfort will be defined by the addition of a cushion, rolled towel, treatment oil or the need for the bedpan to be repositioned

  4. Assess alteration of skin condition at the seat of the patient using the bedpan

    Time frame: 48 hours

    Appearance of stage I redness or pressure sores (redness that does not disappear) on the patient's seat, after using the bedpan

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

    Time frame: 48 hours

    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).

  6. Assess the risk factors associated with the onset of pain when placing a bedpan.

    Time frame: 48 hours

  7. Assess the difficulty of positioning and removing the bedpan.

    Time frame: 48 hours

    Painfulness of placing and removing the bedpan, assessed by the caregiver using a Likert scale between 1 (easy) and 5 (impossible alone)

  8. Assess bedpan stability during use

    Time frame: 48 hours

    Stability will be evaluated by the tilting, or not, of the bedpan during use by the patient.

  9. Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jules Galy

CONTACT

[email protected]

(+33) 253482835

Thomas RULLEAU, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: RIDAECUBA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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