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

NCT06346119 | Recruiting

• 1 other identifier: PI-2023-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Reaction Anxiety; Difficult or Failed Intubation

Keywords

chemical restraint; intensive care; intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• self-extubations

  1 year

• patient discomfort

  T=0, T=30 nimutes, T=60 minutes, T= 90 minutes

• respiratory rate

  T=0, T=30 nimutes, T=60 minutes, T= 90 minutes

• Ratio chemical restraint use

  1 year

• cardiac frequency

  T=0, T=30 nimutes, T=60 minutes, T= 90 minutes

Study Arms (2)

control

NO INTERVENTION

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

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier de Niort: lead

Study Sites (1)

Centre Hospitalier de Niort

Niort, 79000, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean Marc M. Le Guevel, Nurse coordinator

  Centre Hospitalier de Niort - France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Marc M. Le Guevel, Nurse coordinator

CONTACT

549783254; jean-marc.leguevel@ch-niort.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: April 3, 2024
• Study Start: February 27, 2023
• Primary Completion: January 5, 2024
• Study Completion: December 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)