Clinical trial NCT03118401: Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
Official title: Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Homes for the Aged
Intestinal Elimination
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of nights with stools during the follow-up period
timeFrame: Week 10
Secondary outcomes:
measure: Evolution in number of nights with stool
timeFrame: Week 10
measure: Evolution in number of laxative medication
timeFrame: Week 10
measure: Satisfaction questionary
timeFrame: Week 10
Other outcomes:
Locations:
city: Ussel
country: France
facility: EHPAD les Ecureuils
Study officials:
affiliation: Ussel Hospital
name: Pascale SEIGNEURIN-HERISSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.