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

NCT03118401 | Completed

• 1 other identifier: I16025 (RITUELIM)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Homes for the Aged; Intestinal Elimination

Outcome Measures

Primary Outcomes (1)

• Number of nights with stools during the follow-up period

  Number of nights with stools during the follow-up period

  Week 10

Secondary Outcomes (3)

• Evolution in number of nights with stool

  Week 10

• Evolution in number of laxative medication

  Week 10

• Satisfaction questionary

  Week 10

Study Arms (2)

Ritual of stool

EXPERIMENTAL

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

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

Other: Usual practice

Interventions

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

Ritual of stool

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

Usual practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

EHPAD les Ecureuils

Ussel, 19208, France

Location

Related Publications (1)

• 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.

  PMID: 36088731 RESULT

Study Officials

• Pascale SEIGNEURIN-HERISSE

  Ussel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: July 21, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)