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Evaluation of Touch Massage on Anxiety in Critically Ill Patients (REaLAX)

V

Versailles Hospital

Status

Completed

Conditions

Anxiety

Treatments

Procedure: touch massage

Study type

Interventional

Funder types

Other

Identifiers

NCT03030482
P14/10_REaLAX

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Touch massage
Experimental group
Description:
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
Treatment:
Procedure: touch massage
control
No Intervention group
Description:
standard care ICU

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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