Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People (RITUELIM)

July 16, 2025 updated by: University Hospital, Limoges

As they age, the intestinal elimination function can be altered by external factors. Sleeping is also a vital need for maintaining health. Sleep time varies with age (from 18h / day for an infant to 7h30 on average for an adult) and sleep disorders increase with age (INSERM source). In our study, the night is from 9 pm to 7 am, corresponding to the working hours of the night shift. Between 42% and 50% of episodes of wakefulness of more than 4 minutes in EHPAD are due to noise, light or the practice of care related to incontinence. 87% of all incontinence care practices have been associated with wake-up episodes. A personalized day care program would allow residents to improve the quality of their sleep by minimizing stools at night and therefore interventions by caregivers.

The ritual of stools, can be defined as the set of rules to observe to defecate in good physiological, physical conditions:

  • Be in a suitable place for intestinal elimination: personal bathroom preferably on the toilet or on a pierced chair that will perhaps be more secure and comfortable with the armrests. The position to be taken is important.
  • Propose a small bench to put under the feet to raise the knees higher than the hips and increase the abdominal pressure.
  • Preserve the visual and auditory intimacy of the resident at the time of defecation. Failure to do so may result in the person repressing his desire to defecate.
  • Allow the resident the time needed on the toilets the doorbell at hand and with the assurance that the caregiver will come back in a short time. Do not press it and do not forget it, privilege the autonomy and check that there is toilet paper.

The establishment of the stool ritual is not intended to reduce the amount of stool by day, but it aims to postpone the nighttime exemption on the day, and does not prevent the stool emission to other times of the day or night.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ussel, France, 19208
        • EHPAD les Ecureuils

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dependent elderly people living in institutions for elderly dependents.
  • GIR 1 or 2
  • Residents being able to sit in a seated position on a pierced chair or a safe toilet.
  • Residents who have lived in the institution for at least 1 month in order to limit the biases due to the change of place of life

Exclusion Criteria:

  • Residents with the physical and cognitive abilities to go to the toilet alone wisely.
  • Residents with stomies
  • Residents with a history of intestinal occlusion
  • Residents participating in another study.
  • Residents under guardianship or safeguard justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ritual of stool
During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start the implementation period of ritual of stool. From the stool diary: - will be determined the stool profile of each resident over 1 week and application of the ritual of stool the following week At the end of this second period, data will be collected on an individual stool diary in for 4 weeks
Other: Ritual of stool
During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start the implementation period of ritual of stool. From the stool diary: - will be determined the stool profile of each resident over 1 week and application of the ritual of stool the following week At the end of this second period, data will be collected on an individual stool diary in for 4 weeks
Other: Usual practice

During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start 2 weeks without data collection. Patient will be follow in usual practice.

At the end of this second period, data will be collected on an individual stool diary in for 4 weeks
Other: Usual practice

During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start 2 weeks without data collection. Patient will be follow in usual practice.

At the end of this second period, data will be collected on an individual stool diary in for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of nights with stools during the follow-up period
Time Frame: Week 10
Number of nights with stools during the follow-up period
Week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution in number of nights with stool
Time Frame: Week 10
Difference in number of nights with stool between initial observation period and follow-up period in each of the 2 randomization groups
Week 10
Evolution in number of laxative medication
Time Frame: Week 10
Difference in the number of laxative medication between initial observation period and follow-up period in each of the 2 randomization groups
Week 10
Satisfaction questionary
Time Frame: Week 10
At the end of the study, satisfaction of the caregivers who participated in the implementation of the ritual of stools concerning the interest of this ritual by means of a satisfaction questionary
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Limoges

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascale SEIGNEURIN-HERISSE, Ussel Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I16025 (RITUELIM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Homes for the Aged

Clinical Trials on Ritual of stool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings