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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Niort

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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)

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
1 year

Secondary outcomes

1

self-extubations

Comparison of the proportion of self-extubations between the 2 groups

Time frame
1 year
2

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

Time frame
T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
3

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

Time frame
T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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