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

Patient hospitalized in intensive care unit and under invasive mechanical ventilation are recruited in this research. Survivors of critical illness who are hospitalized in intensive care and have been intubated and sedated, experience a lot of problems that begin in the intensive care unit (ICU) and can continue after discharge from intensive care or even hospital.

When questioned, 41.3% of patients hospitalized in intensive care express having felt anxiety. Life in intensive care is a source of numerous, repetitive and frequent psychic traumas whose affective disorders (anxiety, stress, despair) are insufficiently detected. Barriers to better living exist in intensive care; they can be responsible for psychological manifestations such as anxiety.

One of the most distressing psychological experiences for patients receiving mechanical ventilatory support would be anxiety, defined as a state characterized by apprehension, agitation, increased motor tension, autonomic arousal and restlessness. fearful withdrawal.

Prolonged bed rest also has repercussions on the psyche of the patient who is easily anxious, confused and depressed. This prolongs the length of hospital stay. Anxiety is a feeling of dread, fear of lack of control which can manifest as agitation and fearful withdrawal, a reaction to perceived danger; also, a manifestation that can affect the psyche and physiological stability.

According to Nelson et al, between 55 and 75% of patients hospitalized in intensive care report an experience of pain, discomfort or anxiety.

At the same time, disorders of external origin (medical devices, iatrogenics) can have long-term repercussions. They can be induced by the ventilation device and result in lesions in the larynx, vocal cords, trachea such as edema, necrosis related to the balloon and pneumopathy acquired under mechanical ventilation. The objective is therefore to reduce the time of invasive ventilation in order to reduce the risk of the appearance of these complications.

Complications of a stay in intensive care or resuscitation can also be the consequence of prolonged bed rest and result in muscle weakness, cognitive disorders, psychological difficulties, reduced physical function and reduced quality of life. Early interventions such as mobilizations or active exercise, or both, can decrease the impact of severe disease sequelae. These mobilizations and this phase of ventilatory weaning themselves generate anxiety through the actions that this requires: sensory and motor stimulation, mobilization in an environment that the patient does not yet know because of his recent awakening, gestures imposed and not free due to the equipment (probes, catheters, multiple infusion lines), difficulty in expressing oneself due to the intubation probe.

Communication is the only way to prevent and try to reduce these painful experiences. Verbal and non-verbal communication (look, touch) and a body care approach are advised.

Weaning therefore generates anxiety. To reduce it, it is recommended to use relaxation therapies.

RELATIONAL TOUCH The practice of touch is part of the proper role of nurses (IDE) and caregivers (AS). It is present in more than 85% of the care provided by nurses, nursing auxiliaries and childcare auxiliaries.

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. It is mutually consented, intentional care. Its purpose is to communicate, reassure and provide comfort and confidence. A relational approach to create a link between the caregiver and the person cared for. Anxiolytic massages can be used in intensive care. Several studies have assessed the impact of relational touch in conscious or unconscious patients in intensive care. They demonstrate that relational touch brings relaxation and appeasement. In 47.5% of patients, a decrease in the Behavioral Pain Scale (BPS) was observed. The SRLF consensus conference in 2010 recommends the use of massage for anxiolytic purposes.

THE EDGE OF THE BED After 7 days of mechanical ventilation, 25-33% of patients have clinically evident neuromuscular weakness.

Sitting is a mobilization technique which, depending on the patient's autonomy, can be considered active, active assisted or passive active. The edge of the bed is a positioning of the patient on the edge of the bed in order to assess the patient's tolerance and capacity in the sitting position. Seated balance work can be done in bed or in an armchair. Consideration should be given to placing the patient in a seated position (bed-armchair or armchair) early on as soon as sufficient vigilance and participation have been obtained. Maintaining the seated position can be passive or active. The edge of the bed does not cause any deleterious effects for patients. Mobilization, considered as a common care by caregivers, is a source of suffering by patients described as Horror in patient testimonials.

Early mobilization involves moving the patient quickly to reduce the risks outlined above.

ACTIVE AND PASSIVE MOBILIZATION Mobilization according to its etymology from the Latin "mobilis", that is to say mobile, means that one can move, which can move easily. In the medical context mobilization is the action of moving a limb or a joint or the whole body in a passive or active way (especially after prolonged immobilization either using massage, cycling or other means exerted by the physiotherapist or by the carer on medical prescription). It is part of the process of weaning from invasive mechanical ventilation in intensive care. It must be started within 24-48 hours, following the patient's awakening and makes it possible to reduce the length of stay in intensive care. Early active mobilization makes it possible to anticipate or reduce the harmful effects of bed rest. It is as justified as passive mobilization. The implementation of passive or active mobilization is recommended as soon as possible so that the patient recovers his mobility and his autonomy in order to avoid sequelae.

BED AND ITS EFFECTS Bed rest or acute inactivity associated with hospitalization or the patient's medical condition poses a deleterious threat to functional capacity and muscle tissue.

From 24 hours of immobility, this position can have negative consequences on many functions, as described in the research of Dr. Truong:

* At the respiratory level: atelectasis, pneumonia, reduction in forced vital capacity (FVC) and reduction in maximum inspiratory pressure. * At the cardiovascular level: decrease in the size of the heart and left ventricle, decrease in cardiac output, decrease in ejection volume, orthostatic hypotension, decrease in peripheral venous capital and function disorders circulatory. * At the metabolic level: significant changes and disruption of endocrine activity. * At the gastrointestinal level: disruption of transit (ileus are frequent), of the urinary system and a reduction in daily caloric intake. * At the cutaneous level: the skin becomes fragile, which increases the risk of bedsores. * At the musculoskeletal level: reduced muscle mass causes a decrease in strength, elasticity (connective tissues) and a loss of joint mobility (eg capsulitis) which can cause muscle atrophy. * At the nervous level: risk of severe neuromyopathies Complications due to immobility in intensive care can persist after discharge from hospital.

Research assumptions We hypothesize that the practice of relational touch by the paramedical team during the first early mobilization session will bring about a decrease in anxiety, which could make it possible to increase the duration of bedside and possibly facilitate ventilatory weaning. .

If our study shows a decrease in anxiety in patients who have benefited from a bedside session with relational touch, the benefits will be:

* Lengthening of bed edge duration; * Reduction in the use of psychotropic drugs; * Reduction in the number of days of mechanical ventilation.

Benefits:

This practice will reduce stress among caregivers. Comfort care will be valued in the same way as technical care. The expected economic benefit involves the reduction of decubitus complications and therefore their cost and the reduction of hospitalization times in intensive care.

Main objective of the research To study the impact of relational touch versus standard care on patient anxiety, with the Face Anxiety Scale, during the 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.

Secondary objectives

To study the impact of relational touch versus standard care on the following patient parameters:

* Assessment of caregiver anxiety with the Spielberger inventory * Increasing the duration of the bedside session * Variations in pain, assessed by the Behavioral Pain Scale at the start and 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); * The duration of the bedside session with the scope stopwatch; * 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 the resuscitation and intensive care unit (maximum D28 after the first bedside session).

We will evaluate the evolution of the patient's anxiety score during the first bedside session, measured by the caregiver with the Face Anxiety Scale (FAS): difference between the beginning and the end of the bedside on the score at the Patient Anxiety Scale.

Experimental plan 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 cluster trial experimental design is indicated to avoid intervention contamination biases in this care setting (Goldstein et al., 2018); the stepped-wedge design was chosen among the types of cluster trials in view of the low risk of the intervention under study, the desire of the centers to implement this intervention eventually in their practice, to improve the power statistics and in view of the number of centers available.

Description of measures taken to reduce and avoid bias Identification of subjects

As part of this research, the subjects will be identified as follows:

center n° (3 numeric positions) - person selection order n° in the center (4 numeric positions) - surname initial - first name initial This reference is unique and will be kept for the duration of the research. Randomization The randomization of the centers (1:1:1:1) will be centralized and carried out from a list compiled in advance by the URC statistician and validated according to the procedures of the AP-HP promoter.

Randomization of centers Inclusion process (18 months) Center A Period without relational touch Formation Period with relational touch Period with relational touch Period with relational touch Period with relational touch Center B Period without relational touch Period without relational touch Formation Period with relational touch Period with relational touch Period with relational touch Center C Period without relational touch Period without relational touch Period without relational touch Formation Period with relational touch Period with relational touch Center D Period without relational touch Period without relational touch Period without relational touch Period without relational touch Formation Period with