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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030482
Recruitment Status : Unknown
Verified August 2018 by Melot Karine, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : January 25, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Melot Karine, Versailles Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anxiety Procedure: touch massage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Touch massage
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
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

No Intervention: control
standard care ICU



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030482


Contacts
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Contact: Karine Melot, RN +33139638356 karine.melot@reachv.org
Contact: Gwenaelle Jacq, RN +33139638356 gjacq@ch-versailles.fr

Locations
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France
Versailles Hospital Recruiting
Le Chesnay, Yvelines, France, 78150
Contact: karine melot, RN    139638356 ext Melot    gjacq@ch-versailles.fr   
Contact: GWENAELLE JACQ, RN    139638356 ext JACQ    gjacq@ch-versailles.fr   
Sponsors and Collaborators
Versailles Hospital
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Responsible Party: Melot Karine, Study principal investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03030482    
Other Study ID Numbers: P14/10_REaLAX
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melot Karine, Versailles Hospital:
Anxiety
intensive care
mechanical ventilation
touch massage
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders