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| ID | Type | Description | Link |
|---|---|---|---|
| CHRD0925 | Other Identifier | HOPITAL NOVO |
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Residents of long-term care facilities are subjected to procedures and treatments that may be painful. The prevalence is 90% among older adults living in institutions. Preventing procedure-induced pain is essential, as the consequences can be even more harmful. Induced pain is defined as "short-term pain caused by a healthcare provider, treatment, or care, under predictable circumstances," according to the UPSA Pain Institute.
For these older adults, personal hygiene is performed in bed by nursing assistants and requires frequent handling and repositioning. It includes dressing and undressing, which are sources of pain. Despite this, these activities are repeated daily because they are essential. Addressing pain is a fundamental criterion for quality of life in older adults.
In many cases, these residents require daily premedication with analgesics to prevent pain caused by personal care. For these residents, who are already on multiple medications, the addition of analgesics increases the risk of drug interactions, leading to more frequent side effects.
For residents who meet the eligibility criteria, a member of the research team-including the physician and the psychomotor therapist-meets with the resident to inform them about the study and obtain their verbal consent, if possible. If the resident is unable to give consent, the information is provided to the family or a trusted representative by phone or during a visit to the nursing home. The representative may ask the care team any questions and give oral consent after sufficient time to consider the matter.
If consent is given, the resident is then enrolled and randomized into the study.
Randomization will be based on the number of days in the first week (5, 6, or 7 days) and will be performed by the investigator in the eCRF.
The psychomotor therapist will provide expertise that the nursing assistants (NAs) will need to apply during their daily care routines throughout the pilot period in order to make care sessions less unpleasant and painful for the residents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resident GIR1 | Experimental | Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing |
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| Resident GIR 2-3 | Experimental | Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing |
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| Resident GIR 3-4 | Experimental | Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard personal hygiene | Other | Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction with ALGOPLUS | Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug profile | Change in the dose of pain medication received, by 3 categories of residents | 4 weeks |
| Satisfaction of care workers | Questionnaire on changes in practices and how they were perceived, before the study and after each bath |
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Inclusion Criteria:
Inclusion criteria common to all groups
Criteria specific to Group 1:
Criteria specific to Group 2:
Criteria specific to Group 3:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vella QUILLIEN | Contact | 01 30 75 51 75 | vella.quillien@ght-novo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vella QUIILIEN | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital NOVO | Recruiting | Pontoise | France |
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| Adapted toilet | Other | Care assistants follow the psychomotor therapist's recommendations for providing appropriate personal care to residents. A new approach to pain prevention developed by a psychomotor therapist and shared with nursing assistants who assist with bedside hygiene for residents experiencing pain of 2 or higher on the ALGOPLUS scale. |
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| 4 weeks |
| Bathing Process | Number of caregivers, duration of care | 4 weeks |