Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital

NCT ID: NCT06346119

Last Updated: 2025-09-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2025-12-31

Brief Summary

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This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation.

Detailed Description

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Conditions

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Reaction Anxiety Difficult or Failed Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the "touch" and the second group will not receive it will be the control arm.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind.

Study Groups

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control

this arm will not received relaxing touch. It's a control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

this arm will received relaxing touch twice a day

Group Type EXPERIMENTAL

this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day

Intervention Type OTHER

Patients who will be included in this arm will receive massage twice a day of the head (10 minutes), feet (10 minutes) and hands (10 minutes)

Interventions

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this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day

Patients who will be included in this arm will receive massage twice a day of the head (10 minutes), feet (10 minutes) and hands (10 minutes)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female over 18 years of age
* Intubated and sedated man or woman
* Extubation within 48 hours
* Intubation of more than 48 hours in total
* Patient in intensive care at Niort hospital
* The trusted person or referent accepting the patient's participation
* Patient affiliated to the social security system

Exclusion Criteria

* Known pregnancy
* Patient who refused to participate in the study after the fact
* Patients under long-term antidepressant treatment (treatment longer than 3 months)
* Patients under guardianship or curatorship
* Patient deprived of liberty
* Skin lesions on the hands/feet/head (wounds, erythema, burns, bedsores, phlyctenes)
* Inclusion in another clinical study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Niort

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Marc M. Le Guevel, Nurse coordinator

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Niort - France

Locations

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Centre Hospitalier de Niort

Niort, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Marc M. Le Guevel, Nurse coordinator

Role: CONTACT

549783254 ext. +33

Other Identifiers

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PI-2023-01

Identifier Type: -

Identifier Source: org_study_id

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