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Evaluation of Touch Massage on Anxiety in Critically Ill Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03030482
Acronym
REaLAX
Enrollment
70
Registered
2017-01-25
Start date
2017-04-20
Completion date
2020-04-30
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, intensive care, mechanical ventilation, touch massage

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.

Interventions

PROCEDUREtouch 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

Sponsors

Versailles Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating60 minutesTotal 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

MeasureTime frameDescription
Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).60 minutesPatient 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, communicating60 minutesPain 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026