Skip to main content
OpenTrials
Completed

NCT Number: NCT03118401

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD les Ecureuils

Ussel, 19208, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ritual of stool

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 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

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

Primary outcomes

  1. Number of nights with stools during the follow-up period

    Time frame: Week 10

    Number of nights with stools during the follow-up period

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: RITUELIM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Jul 20, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.