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OpenTrials
Completed

NCT Number: NCT03030482

Evaluation of Touch Massage on Anxiety in Critically Ill Patients

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Versailles Hospital

Le Chesnay, Yvelines, 78150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

touch massage

Procedure

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

Primary outcomes

  1. Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating

    Time frame: 60 minutes

    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.

Secondary outcomes

  1. Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).

    Time frame: 60 minutes

    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.

  2. Measure the analgesic effect of touch massage to critically ill patient awake, communicating

    Time frame: 60 minutes

    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.

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study title

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

Acronym: REaLAX

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2017
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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