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NCT Number: NCT06346119

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

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.

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Key information

Conditions

Reaction Anxiety Anxiety Disorders Difficult or Failed Intubation Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Niort

Niort, 79000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. chemical restraint

    Time frame: 1 year

    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)

Secondary outcomes

  1. self-extubations

    Time frame: 1 year

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

  2. patient discomfort

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

    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

  3. respiratory rate

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

    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

  4. Ratio chemical restraint use

    Time frame: 1 year

    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.

  5. cardiac frequency

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Marc M. Le Guevel, Nurse coordinator

CONTACT

[email protected]

549783254 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Niort

Other

Registry information

Acronym: ETDR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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