Prevention of Pain Induced During Bed Bath in Ehpad

Official title

Prevention of Pain Induced During Bed Bath in Ehpad, by Adapted Mobilization Techniques : A Single Case Experimental Design (ABAB) Study

Overview

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.

Detailed description

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.

Interventions

• Other Standard personal hygiene
  Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist.
• Other 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.

Primary outcome measures

• Pain reduction with ALGOPLUS [Time frame: 4 weeks]

Secondary outcome measures (3)

• Drug profile [Time frame: 4 weeks]
• Satisfaction of care workers [Time frame: 4 weeks]
• Bathing Process [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Hôpital NOVO — Pontoise

Identifiers

NCT: NCT07691385 · 2025-A02024-45 · CHRD0925

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗