NCT07691385

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Nov 2027

First Submitted

Initial submission to the registry

June 23, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 6, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

June 23, 2026

Last Update Submit

July 8, 2026

Conditions

Geriatric Care

Keywords

Induced painNursing homepersonal hygienemobilityNon-pharmacological approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Drug profile

    4 weeks

  • Satisfaction of care workers

    4 weeks

  • Bathing Process

    4 weeks

Study Arms (3)

Resident GIR1

EXPERIMENTAL

Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing

Other: Standard personal hygieneOther: Adapted toilet

Resident GIR 2-3

EXPERIMENTAL

Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing

Other: Standard personal hygieneOther: Adapted toilet

Resident GIR 3-4

EXPERIMENTAL

Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing

Other: Standard personal hygieneOther: Adapted toilet

Interventions

Standard personal hygieneOTHER

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

Resident GIR 2-3Resident GIR 3-4Resident GIR1
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.

Resident GIR 2-3Resident GIR 3-4Resident GIR1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital NOVO

Pontoise, France

RECRUITING

Study Officials

  • Vella QUIILIEN

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vella QUILLIEN

CONTACT

01 30 75 51 75vella.quillien@ght-novo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 8, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)