Geriatric CareTODOMOBNCT07691385
Prevention of Pain Induced During Bed Bath in Ehpad
A study testing Standard personal hygiene and Adapted toilet in people with Geriatric Care, run by Hôpital NOVO at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Geriatric Care
- What is being tested?
- Standard personal hygiene and Adapted toilet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital NOVO
Pontoise
Vella QUILLIEN, 01 30 75 51 75, vella.quillien@ght-novo.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Care
- Being tested
- Standard personal hygiene, Adapted toilet
- Keywords
- Induced pain, Nursing home, personal hygiene, mobility, Non-pharmacological approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard personal hygieneOther
Caregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist.
Adapted toiletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resident GIR1 | Experimental | Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing Receives: Other: Standard personal hygiene; Other: Adapted toilet |
| Resident GIR 2-3 | Experimental | Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing Receives: Other: Standard personal hygiene; Other: Adapted toilet |
| Resident GIR 3-4 | Experimental | Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing Receives: Other: Standard personal hygiene; Other: Adapted toilet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction with ALGOPLUS
Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing.
Measured: 4 weeks
Secondary outcomes (3)
Drug profile
Change in the dose of pain medication received, by 3 categories of residents
Measured: 4 weeks
Satisfaction of care workers
Questionnaire on changes in practices and how they were perceived, before the study and after each bath
Measured: 4 weeks
Bathing Process
Number of caregivers, duration of care
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start6 Jul 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vella QUIILIEN, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691385
- Sponsor's protocol ID
- 2025-A02024-45
- Other IDs
- CHRD0925
- Acronym
- TODOMOB
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pain Induced During Bed Bath in Ehpad, by Adapted Mobilization Techniques : A Single Case Experimental Design (ABAB) Study
- ClinicalTrials.gov ID
- NCT07691385
- Acronym / sponsor ID
- TODOMOB / 2025-A02024-45
- Conditions
- Geriatric Care
- Keywords
- Induced pain, Nursing home, personal hygiene, mobility, Non-pharmacological approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resident GIR1 | Experimental | Other: Standard personal hygiene, Other: Adapted toiletResident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing |
| Resident GIR 2-3 | Experimental | Other: Standard personal hygiene, Other: Adapted toiletResidents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing |
| Resident GIR 3-4 | Experimental | Other: Standard personal hygiene, Other: Adapted toiletResidents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Residents requiring high doses of analgesics (Level 3) before bathing
- GIR (Iso-Resource Group) 1, with multiple medical conditions
- Residents requiring Level 1 or 2 analgesics before bathing
- GIR (Iso-Resource Group) 2 or 3, with multiple medical conditions
- Residents experiencing pain without analgesics prior to bathing
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard personal hygieneCaregivers follow the standard guidelines for personal hygiene. They are not trained by the psychomotor therapist. | Other | Resident GIR 2-3, Resident GIR 3-4, Resident GIR1 |
| Adapted toiletCare 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. | Other | Resident GIR 2-3, Resident GIR 3-4, Resident GIR1 |
Primary outcome
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.
3 secondary outcomes
Drug profile
Time frame: 4 weeks
Satisfaction of care workers
Time frame: 4 weeks
Bathing Process
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Geriatric Care
Not yet recruiting
Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People.
Geriatrics, Oral Health Care
Recruiting
Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.
Care Delivery, Geriatrics
Recruiting
New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance
Transitional Care, Remote Patient Monitoring (RPM)
RecruitingObservational study
Analgesia Methods and Early Mobilization in Geriatric ICU Patients After Major Surgery
Postoperative Pain, Delirium - Postoperative
Active, not recruitingObservational study
ASA or CFS for ICU Prediction in Geriatric Hip Fracture
Hip Fracture Surgeries, Geriatric Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vella QUIILIEN principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard personal hygiene and Adapted toilet in people with Geriatric Care, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vella QUILLIEN (01 30 75 51 75, vella.quillien@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction with ALGOPLUS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.