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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118401
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Homes for the Aged Intestinal Elimination Other: Ritual of stool Other: Usual practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People
Actual Study Start Date : July 21, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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

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





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118401


Locations
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France
EHPAD les Ecureuils
Ussel, France, 19208
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Pascale SEIGNEURIN-HERISSE Ussel Hospital
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03118401    
Other Study ID Numbers: I16025 (RITUELIM)
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No