ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT03118401I16025 (RITUELIM)NCT03118401Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
RITUELIM
Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly PeopleUniversity Hospital, LimogesOtherNoNoNo
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.
CompletedJuly 21, 2017October 15, 2019October 15, 2019N/AInterventionalNoRandomizedParallel AssignmentAt 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:
/ Experimental group Implementation period: From the stool diary: - determine the stool profile of each resident over 1 week (W5)
/ 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 weeksPreventionNone (Open Label)Number of nights with stools during the follow-up periodWeek 10Number of nights with stools during the follow-up periodEvolution in number of nights with stoolWeek 10Difference in number of nights with stool between initial observation period and follow-up period in each of the 2 randomization groupsEvolution in number of laxative medicationWeek 10Difference in the number of laxative medication between initial observation period and follow-up period in each of the 2 randomization groupsSatisfaction questionaryWeek 10At 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 questionary250Homes for the AgedIntestinal EliminationRitual of stoolExperimentalDuring 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 weeksUsual practiceOtherDuring 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 weeksOtherRitual 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 weeksRitual of stoolOtherUsual 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 weeksUsual practice
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
All18 YearsN/ANoPascale SEIGNEURIN-HERISSEPrincipal InvestigatorUssel HospitalEHPAD les EcureuilsUssel19208FranceFranceDecember 2019April 13, 2017April 17, 2017April 18, 2017December 2, 2019December 2, 2019December 3, 2019SponsorNo