Homes for the AgedRITUELIMNCT03118401
Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
A study testing Ritual of stool and Usual practice in people with Homes for the Aged and Intestinal Elimination, run by University Hospital, Limoges at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homes for the Aged, Intestinal Elimination
- What is being tested?
- Ritual of stool and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Conditions
- Homes for the Aged, Intestinal Elimination
- Being tested
- Ritual of stool, Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritual of stoolOther
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
Usual practiceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ritual of stool | Experimental | 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 Receives: Other: Ritual of stool |
| Usual practice | Other | 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 Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nights with stools during the follow-up period
Number of nights with stools during the follow-up period
Measured: Week 10
Secondary outcomes (3)
Evolution in number of nights with stool
Difference in number of nights with stool between initial observation period and follow-up period in each of the 2 randomization groups
Measured: Week 10
Evolution in number of laxative medication
Difference in the number of laxative medication between initial observation period and follow-up period in each of the 2 randomization groups
Measured: Week 10
Satisfaction questionary
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
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start21 Jul 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Homes for the AgedStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the end of the first 4 weeks of collection of the data on an individual stool diary with usual care of the resident, a randomization will be carried out dividing the patients according to the following groups: 1. / Experimental group Implementation period: From the stool diary: - determine the stool profile of each resident over 1 week (W5) 2. / Control group: without modification of practices and without data collection from W5 to W6. At the end of this second period, data were collected on an individual stool diary in each of the two groups for 4 weeks
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale SEIGNEURIN-HERISSE, Principal investigator, Ussel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118401
- Sponsor's protocol ID
- I16025 (RITUELIM)
- Acronym
- RITUELIM
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2017
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seigneurin-Herisse P, Toniolo J, Marchat N, Micallef L, Labrunie A, Delaide V, Beloni P. Impact of a person-centered bowel program on the frequency of nights with bowel movement in dependent elderly people in nursing home: A single-centre randomized controlled trial. Int J Nurs Stud. 2022 Nov;135:104348. doi: 10.1016/j.ijnurstu.2022.104348. Epub 2022 Aug 13.
PubMed 36088731
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
- ClinicalTrials.gov ID
- NCT03118401
- Acronym / sponsor ID
- RITUELIM / I16025 (RITUELIM)
- Conditions
- Homes for the Aged, Intestinal Elimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 18 Apr 2017 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At the end of the first 4 weeks of collection of the data on an individual stool diary with usual care of the resident, a randomization will be carried out dividing the patients according to the following groups: 1. / Experimental group Implementation period: From the stool diary: - determine the stool profile of each resident over 1 week (W5) 2. / Control group: without modification of practices and without data collection from W5 to W6. At the end of this second period, data were collected on an individual stool diary in each of the two groups for 4 weeks
| Arm | Type | Receives |
|---|---|---|
| Ritual of stool | Experimental | Other: Ritual of stoolDuring 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 |
| Usual practice | Other | Other: Usual practiceDuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Ritual of stoolDuring 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 |
| Usual practiceDuring 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 |
Primary outcome
Number of nights with stools during the follow-up period
Time frame: Week 10
Number of nights with stools during the follow-up period
3 secondary outcomes
Evolution in number of nights with stool
Time frame: Week 10
Evolution in number of laxative medication
Time frame: Week 10
Satisfaction questionary
Time frame: Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Results publication: PubMed 36088731Seigneurin-Herisse P, Toniolo J, Marchat N, Micallef L, Labrunie A, Delaide V, Beloni P. Impact of a person-centered bowel program on the frequency of nights with bowel movement in dependent elderly people in nursing home: A single-centre randomized controlled trial. Int J Nurs Stud. 2022 Nov;135:104348. doi: 10.1016/j.ijnurstu.2022.104348. Epub 2022 Aug 13.
- Individual participant dataSharing planned: No
Related trials for Homes for the Aged
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Enrolling by invitationObservational study
CHOICE+ Quality Improvement for Long Term Care Homes
Long Term Care Homes, Malnutrition Elderly
Recruiting
Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes
Mild Cognitive Impairment, Cognitive Function
Not yet recruiting
Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes.
Deafness
Recruiting
Assessment of the Impact of Oral Health Training for Caregivers on the Oral Health-related Quality of Life of Residents in Nursing Homes
Oral Health Training
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. This study is not recruiting at the moment.
Pascale SEIGNEURIN-HERISSE principal investigator
Ussel Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritual of stool and Usual practice in people with Homes for the Aged and Intestinal Elimination, run by University Hospital, Limoges at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of nights with stools during the follow-up period (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118401, which also lists 1 linked publication.
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 20 Jul 2025.