Recruiting NCT06346119
Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day.
- Who it may be relevant to
- Registry conditions: Reaction Anxiety, Difficult or Failed Intubation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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)
Primary outcome measures
- chemical restraint [Time frame: 1 year]
Secondary outcome measures (5)
- self-extubations [Time frame: 1 year]
- patient discomfort [Time frame: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes]
- respiratory rate [Time frame: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes]
- Ratio chemical restraint use [Time frame: 1 year]
- cardiac frequency [Time frame: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier de Niort — Niort
Identifiers
NCT: NCT06346119 · PI-2023-01