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

Homes for the Aged Clinical Trial

— RITUELIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118401
• Other study ID #: I16025 (RITUELIM)
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Homes for the Aged
• Intestinal Elimination

Intervention

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
• 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

Locations

Country	Name	City	State
France	EHPAD les Ecureuils	Ussel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of nights with stools during the follow-up period	Number of nights with stools during the follow-up period	Week 10
Secondary	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	Week 10
Secondary	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	Week 10
Secondary	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	Week 10