Evaluation of Touch Massage on Anxiety in Critically Ill Patients

NCT ID: NCT03030482

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

touch massage

Intervention Type 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

control

standard care ICU

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Melot Karine

Study principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Versailles Hospital

Le Chesnay, Yvelines, France

Site Status

Countries

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France

Other Identifiers

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P14/10_REaLAX

Identifier Type: -

Identifier Source: org_study_id

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