Early Mobilisation and Relational Touch Practice on Intubated Patients of Intensive Care Unit

Summary

41.3% of patients hospitalized in intensive care express feeling anxiety when they are systematically questioned. Ventilatory weaning is one of the moments of anxiety for the patient. While being conscious he must tolerate invasive ventilation. The early mobilization of patients in intensive care must be started early, within 24-48 hours, after the patient wakes up. Early mobilization is part of the weaning process from invasive mechanical ventilation in intensive care. It is recommended to reduce it to use relaxation therapies. Several studies have assessed the impact of relational touch in conscious or unconscious patients in intensive care. The SRLF consensus conference in 2010 recommends the use of massage for anxiolytic purposes.

This study aims to assess the impact of relational touch versus standard care on anxiety during the first bedside session, in intubated intensive care patients ventilated for at least 48 hours and presenting with RASS (Richmond agitation sedation scale). ) from 0 to -1.

The study will aussi assess the impact of relational touch versus standard care on the following patient parameters:

* Evaluation of caregiver anxiety with the Spielberger inventory before and after the session
* Increasing the duration of the bedside session;
* Variations in pain, assessed by the Behavioral Pain Scale (BPS) at the end of the session;
* The level of agitation/vigilance at the beginning and at the end of the session with the Richmond agitation-sedation scale (RASS);
* Induced variations in blood pressure;
* Induced variations in oxygen saturation;
* The variations induced on the respiratory rate;
* The variations induced on the heart rate;
* The need to prescribe psychotropic drugs on the day of the first bedside;
* Reduction in the number of days of invasive mechanical ventilation between the first bedside session and discharge from intensive care unit (maximum D28 after the first bedside session).

This is a national, multicenter, cluster, randomized, controlled trial with 4-stage stepped-wedge design (1:1:1:1 randomization), phase III, superiority, open-label, comparing systematic practice relational touch by the paramedical team during bedside sessions, versus standard care (without relational touch).

The benefit is above all for the patient with a better experience of bedside sessions and a reduction in ventilation time, therefore bed rest, leading to a reduction in decubitus complications. The expected economic benefit involves the reduction of decubitus complications and therefore their cost and the reduction of hospitalization times in intensive care.

Conditions

• Ventilation Therapy

Interventions

OTHER

Relational touch practice

Relational touch practice during the first bedside session. Touch in care aims to improve the patient's perception of potentially painful or anxiety-provoking acts of care. It is based on techniques of skin contact, developing and deepening.

Sponsors & Collaborators

• GIRCI IDF

  collaborator UNKNOWN

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Katia Nadaud, degree of nurse · ICU, Ambroise Paré Hospital - APHP

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• France

Study Locations