Evaluation of Touch Massage on Anxiety in Critically Ill Patients

Study Overview
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Brief Summary
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Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures. anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions. The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.

Official Title
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Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: touch massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (age≥18 years) hospitalized in Intensive Care Unit > 24 h Requiring mechanical ventilation or not Securité Sociale affiliated Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back) No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment Exclusion Criteria: Pregnant Legal guardianship Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism, Patient with upper limbs neuromuscular disorders Cutaneous lesion (zone of touch massage) Temperature ≥ 38,5°C A positive score of CAM ICU scale Patient refuse to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Touch massage<br>Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety | Procedure: touch massage<br>* Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety<br>|
| No Intervention: control<br>standard care ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating | Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A). | Patient anxiety will be evaluated by the score of anxiety measured in millimeters from 0 to 100 using a Visual analogue scale of anxiety (EVA - A) before and after touch massage session or standard care ICU. | 60 minutes | 
| Measure the analgesic effect of touch massage to critically ill patient awake, communicating | Pain will be evaluated by the pain score measured in millimeters of 0 and 100 with scale visual analog pain (EVA) before and touch massage session or standard care ICU. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, intensive care, mechanical ventilation, touch massage