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Prevention of Pain Induced During Bed Bath in Ehpad (TODOMOB)

8. juli 2026 opdateret af: Hôpital NOVO

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Resident GIR1
Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing
Andet: Standard personal hygiene
Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist.
Andet: Adapted toilet
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.
Eksperimentel: Resident GIR 2-3
Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing
Andet: Standard personal hygiene
Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist.
Andet: Adapted toilet
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.
Eksperimentel: Resident GIR 3-4
Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing
Andet: Standard personal hygiene
Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist.
Andet: Adapted toilet
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain reduction with ALGOPLUS
Tidsramme: 4 weeks
Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drug profile
Tidsramme: 4 weeks
Change in the dose of pain medication received, by 3 categories of residents
4 weeks
Satisfaction of care workers
Tidsramme: 4 weeks
Questionnaire on changes in practices and how they were perceived, before the study and after each bath
4 weeks
Bathing Process
Tidsramme: 4 weeks
Number of caregivers, duration of care
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hôpital NOVO

Efterforskere

  • Ledende efterforsker: Vella QUIILIEN, Hôpital NOVO

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. juli 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025-A02024-45
  • CHRD0925 (Anden identifikator: HOPITAL NOVO)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ældrepleje

Kliniske forsøg med Standard personal hygiene

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