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NCT Number: NCT07691385

Prevention of Pain Induced During Bed Bath in Ehpad

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.

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Key information

Conditions

Geriatric Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard personal hygiene

Other

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

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.

Primary outcomes

  1. Pain reduction with ALGOPLUS

    Time frame: 4 weeks

    Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing.

Secondary outcomes

  1. Drug profile

    Time frame: 4 weeks

    Change in the dose of pain medication received, by 3 categories of residents

  2. Satisfaction of care workers

    Time frame: 4 weeks

    Questionnaire on changes in practices and how they were perceived, before the study and after each bath

  3. Bathing Process

    Time frame: 4 weeks

    Number of caregivers, duration of care

Study contacts

Contact information is provided by the study sponsor or research team.

Vella QUILLIEN

CONTACT

[email protected]

01 30 75 51 75

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: TODOMOB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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