Evaluation of Touch Massage on Anxiety in Critically Ill Patients

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Procedure: touch massage

• Registration Number: NCT03030482
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-21
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-25
• Study Start: 2017-04-20
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Touch massage	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

Primary Outcome Measures

Name	Time	Method
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating	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

Name	Time	Method
Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).	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.
Measure the analgesic effect of touch massage to critically ill patient awake, communicating	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.

Trial Locations

Locations (1)

Versailles Hospital; 🇫🇷 Le Chesnay, Yvelines, France