Evaluation of Touch Massage on Anxiety in Critically Ill Patients

Anxiety Clinical Trial

— REaLAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030482
• Other study ID #: P14/10_REaLAX
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: February 2021
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
France	Versailles Hospital	Le Chesnay	Yvelines

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	60 minutes
Secondary	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.	60 minutes