Evaluation of Touch Massage on Anxiety in Critically Ill Patients

NCT03030482 | Completed

• 1 other identifier: P14/10_REaLAX
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; intensive care; mechanical ventilation; touch massage

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes

Secondary Outcomes (2)

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

  60 minutes

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

  60 minutes

Study Arms (2)

Touch massage

EXPERIMENTAL

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

control

NO INTERVENTION

standard care ICU

Interventions

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

Touch massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

Versailles Hospital

Le Chesnay, Yvelines, 78150, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study principal investigator

Study Record Dates

• First Submitted: January 21, 2017
• First Posted: January 25, 2017
• Study Start: April 20, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)