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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Marc M. Le Guevel, Nurse coordinator; Phone Number: +33 549783254; Email: jean-marc.leguevel@ch-niort.fr

Study Locations

• France
  • Niort, France, 79000
    • Recruiting
    • Centre Hospitalier de Niort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; this arm will not received relaxing touch. It's a control arm
Experimental: Experimental; this arm will received relaxing touch twice a day	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical restraint	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-extubations	Comparison of the proportion of self-extubations between the 2 groups	1 year
patient discomfort	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
respiratory rate	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
Ratio chemical restraint use	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.	1 year
cardiac frequency	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Niort
• Investigators: Principal Investigator: Jean Marc M. Le Guevel, Nurse coordinator, Centre Hospitalier de Niort - France

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: intensive care; intubation; chemical restraint
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PI-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No