- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07691385
Prevention of Pain Induced During Bed Bath in Ehpad (TODOMOB)
Prevention of Pain Induced During Bed Bath in Ehpad, by Adapted Mobilization Techniques : A Single Case Experimental Design (ABAB) Study
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Vella QUILLIEN
- Numéro de téléphone: 01 30 75 51 75
- E-mail: vella.quillien@ght-novo.fr
Lieux d'étude
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Pontoise, France
- Recrutement
- Hopital Novo
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Contact:
- Vella QUILLIEN
- Numéro de téléphone: 01 30 75 51 75
- E-mail: vella.quillien@ght-novo.fr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Inclusion criteria common to all groups
- Senior residents
- With a stable Algoplus score of 2 or higher
- Information provided to and consent obtained from the resident or their trusted representative
- Eligible for intervention by a psychomotor therapist
Criteria specific to Group 1:
- Residents requiring high doses of analgesics (Level 3) before bathing
- GIR (Iso-Resource Group) 1, with multiple medical conditions
Criteria specific to Group 2:
- Residents requiring Level 1 or 2 analgesics before bathing
- GIR (Iso-Resource Group) 2 or 3, with multiple medical conditions
Criteria specific to Group 3:
- Residents experiencing pain without analgesics prior to bathing
- GIR (Iso-Resource Group) 3 or 4, with multiple medical conditions
Exclusion Criteria:
- Resident who has previously received treatment from a psychomotor therapist
- Resident capable of washing at the sink (partially) or independently
- Under guardianship, conservatorship, or judicial protection
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Resident GIR1
Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing
|
Caregivers follow the standard guidelines for personal hygiene.
They are not trained by the psychomotor therapist.
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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|
Expérimental: Resident GIR 2-3
Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing
|
Caregivers follow the standard guidelines for personal hygiene.
They are not trained by the psychomotor therapist.
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.
|
|
Expérimental: Resident GIR 3-4
Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing
|
Caregivers follow the standard guidelines for personal hygiene.
They are not trained by the psychomotor therapist.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain reduction with ALGOPLUS
Délai: 4 weeks
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Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing.
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4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Drug profile
Délai: 4 weeks
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Change in the dose of pain medication received, by 3 categories of residents
|
4 weeks
|
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Satisfaction of care workers
Délai: 4 weeks
|
Questionnaire on changes in practices and how they were perceived, before the study and after each bath
|
4 weeks
|
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Bathing Process
Délai: 4 weeks
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Number of caregivers, duration of care
|
4 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Vella QUIILIEN, Hopital Novo
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025-A02024-45
- CHRD0925 (Autre identifiant: HOPITAL NOVO)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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