Reaction AnxietyETDRNCT06346119
Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital
A study testing this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day in people with Reaction Anxiety and Difficult or Failed Intubation, run by Centre Hospitalier de Niort at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reaction Anxiety, Difficult or Failed Intubation
- What is being tested?
- this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day
- Keywords
- chemical restraint, intensive care, intubation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a dayOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (5)
self-extubations
Comparison of the proportion of self-extubations between the 2 groups
Measured: 1 year
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
Measured: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
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
Measured: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
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.
Measured: 1 year
cardiac frequency
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
Measured: T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start27 Feb 2023
- Primary completion5 Jan 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reaction AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Niort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc M. Le Guevel, Nurse coordinator, Principal investigator, Centre Hospitalier de Niort - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346119
- Sponsor's protocol ID
- PI-2023-01
- Acronym
- ETDR
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital
- ClinicalTrials.gov ID
- NCT06346119
- Acronym / sponsor ID
- ETDR / PI-2023-01
- Conditions
- Reaction Anxiety, Difficult or Failed Intubation
- Keywords
- chemical restraint, intensive care, intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier de NiortUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –this arm will not received relaxing touch. It's a control arm |
| Experimental | Experimental | Other: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a daythis arm will received relaxing touch twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a dayPatients 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) | Other | Experimental |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Marc M. Le Guevel, Nurse coordinator principal investigator
Centre Hospitalier de Niort - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day in people with Reaction Anxiety and Difficult or Failed Intubation, run by Centre Hospitalier de Niort at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Marc M. Le Guevel, Nurse coordinator (549783254 ext. +33, jean-marc.leguevel@ch-niort.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chemical restraint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.