Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06346119
Acronym
ETDR
Enrollment
72
Registered
2024-04-03
Start date
2023-02-27
Completion date
2025-12-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult or Failed Intubation, Reaction Anxiety

Keywords

chemical restraint, intensive care, intubation

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.

Interventions

OTHERthis 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)

Sponsors

Centre Hospitalier de Niort
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
chemical restraint1 yearComparison 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

MeasureTime frameDescription
self-extubations1 yearComparison of the proportion of self-extubations between the 2 groups
patient discomfortT=0, T=30 nimutes, T=60 minutes, T= 90 minutesComparison 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
respiratory rateT=0, T=30 nimutes, T=60 minutes, T= 90 minutesComparison 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
Ratio chemical restraint use1 yearRatio per patient corresponding to the number of days with chemical restraint use between inclusion and exclusion/total number of days between inclusion and extubation.
cardiac frequencyT=0, T=30 nimutes, T=60 minutes, T= 90 minutesComparison 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

Countries

France

Contacts

Primary ContactJean Marc M. Le Guevel, Nurse coordinator
jean-marc.leguevel@ch-niort.fr549783254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026