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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
touch massage
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Anxiety, intensive care, mechanical ventilation, touch massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Versailles Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Touch massage

control

Arm 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

standard care ICU

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 21, 2017
Last Updated
February 11, 2021
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03030482
Brief Title
Evaluation of Touch Massage on Anxiety in Critically Ill Patients
Acronym
REaLAX
Official Title
Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, intensive care, mechanical ventilation, touch massage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Touch massage
Arm Type
Experimental
Arm 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
Arm Title
control
Arm Type
No Intervention
Arm Description
standard care ICU
Intervention Type
Procedure
Intervention Name(s)
touch massage
Intervention 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
Primary Outcome Measure Information:
Title
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).
Description
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.
Time Frame
60 minutes
Title
Measure the analgesic effect of touch massage to critically ill patient awake, communicating
Description
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.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Versailles Hospital
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Touch Massage on Anxiety in Critically Ill Patients

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