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Massage may replace meds for agitated ICU patients

NCT ID NCT06346119

Symptom relief Sponsor: Centre Hospitalier de Niort Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether gentle massage (called 'relaxing touch') on the head, feet, and hands can reduce the need for calming drugs in sedated, intubated ICU patients as they wake up. About 72 adults will be randomly assigned to receive either standard care or extra massage twice a day. Researchers will compare how often chemical restraints are used and whether patients show signs of discomfort or try to remove their breathing tube.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
relaxing touch (massage of head, feet, and hands)
What this could lead to
If it works, this could offer a drug-free way to help ICU patients feel calmer as they wake up from sedation, possibly reducing the use of chemical restraints.
What could go wrong
This is a small, early-stage study with only 72 participants at one hospital. The effect may be small or not seen at all, and results may not apply to other ICUs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Difficult or failed intubation Reaction anxiety

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Centre Hospitalier de Niort

    RECRUITING

    Niort, 79000, France

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