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

Not Applicable

Recruiting

• Conditions: Reaction Anxiety; Difficult or Failed Intubation
• Interventions: Other: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day

• Registration Number: NCT06346119
• Lead Sponsor: Centre Hospitalier de Niort

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-01-05
• Study Start: 2023-02-27
• Primary Completion: 2024-01-05
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
chemical restraint	1 year	Comparison of the proportion of patients who received chemical restraint during the sedation release phase until extubation between the two groups (experimental and control arms)

Secondary Outcome Measures

Name	Time	Method
respiratory rate	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes	Comparison of vital parameters between the 2 groups. Comparison between respiratory rate (/min), cardiac rate (/min), pressur (mmHG), and ventilation mode.; Touch could relax patients and thus lower the values of vital parameters. The patients included in a experimal group will be relaxation touch twice per day 12 hours apart
cardiac frequency	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes	Comparison of vital parameters between the 2 groups. Comparison between respiratory rate (/min), cardiac rate (/min), pressur (mmHG), and ventilation mode.; Touch could relax patients and thus lower the values of vital parameters. The patients included in a experimal group will be relaxation touch twice per day 12 hours apart
self-extubations	1 year	Comparison of the proportion of self-extubations between the 2 groups
patient discomfort	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes	Comparison of patient discomfort parameters between the 2 groups. The discomfort will be evaluated thank to body expression (unrest) and facial expression according to the BPS scale. The BPS scale is a behavioral pain scale used in intensive care for the sedated and ventilated adult patient.; There discomfort parameters will be evaluated immediately after the relaxation touch, 30 min after, 60 min after and 90 min after.; The patients included in a experimal group will be relaxation touch twice per day 12 hours apart
Ratio chemical restraint use	1 year	Ratio per patient corresponding to the number of days with chemical restraint use between inclusion and exclusion/total number of days between inclusion and extubation.

Trial Locations

Locations (1)

Centre Hospitalier de Niort; 🇫🇷 Niort, France