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

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 Overview

• Status: Completed
• Conditions: Homes for the Aged; Intestinal Elimination
• Intervention / Treatment: Other: Ritual of stool; Other: Usual practice

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ussel, France, 19208
    • EHPAD les Ecureuils

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of nights with stools during the follow-up period	Number of nights with stools during the follow-up period	Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Pascale SEIGNEURIN-HERISSE, Ussel Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: I16025 (RITUELIM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No