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.

Study Overview

• Status: Recruiting
• Conditions: Geriatric Care
• Intervention / Treatment: Other: Standard personal hygiene; Other: Adapted toilet

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vella QUILLIEN; Phone Number: 01 30 75 51 75; Email: vella.quillien@ght-novo.fr

Study Locations

• France
  • Pontoise, France
    • Recruiting
    • Hôpital NOVO
    • Contact: Vella QUILLIEN; Phone Number: 01 30 75 51 75; Email: vella.quillien@ght-novo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resident GIR1; Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing	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.
Experimental: Resident GIR 2-3; Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing	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.
Experimental: Resident GIR 3-4; Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	4 weeks
Bathing Process	Number of caregivers, duration of care	4 weeks

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: Vella QUIILIEN, Hôpital NOVO

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: mobility; Nursing home; Induced pain; personal hygiene; Non-pharmacological approach
• Other Study ID Numbers: 2025-A02024-45; CHRD0925 (Other Identifier: HOPITAL NOVO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No