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A gentle touch from family may calm the ICU storm

NCT ID NCT07761364

Symptom relief Sponsor: Universidad Autonoma del Estado de Mexico Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a gentle, structured visit from a primary caregiver—including a hand massage and a soft touch to the forehead—can calm the body's stress response in adults admitted to the intensive care unit. Researchers will measure changes in heart rate and blood pressure before, during, and after the 20-minute contact. The goal is to see if this simple human connection can help stabilize vital signs in critically ill patients.

What this could mean

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

Active substance
Standardized therapeutic physical contact from a primary caregiver, including gentle hand massage and forehead touch during a 20-minute visit.
What this could lead to
If effective, this simple, drug-free intervention could become a low-cost way to ease stress and stabilize vital signs in ICU patients, potentially improving recovery.
What could go wrong
This is a small, early-stage trial, and the effect on vital signs may be modest or vary widely between patients. The intervention's benefits might not extend beyond the short visit or translate to better long-term outcomes.

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 80 people

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

Started

Aug 2026

Expected to finish

Aug 2026

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 to 59 years

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 Patient Criteria: * Adults aged 18 years or older. * Admission to the intensive care unit (ICU) for 24 to 48 hours. * Richmond Agitation-Sedation Scale (RASS) score between -3 and -1 or between 0 and +3. * Glasgow Coma Scale score greater than 13. Primary Caregiver Criteria: * Identified as the patient's primary caregiver. * Willing and able to participate in the study. * Provides written informed consent prior to study participation. Exclusion Criteria Patient Criteria: * Diagnosis of a neurological disorder (e.g., cerebrovascular disease or stroke). * Multiple organ dysfunction syndrome (MODS). * Unstable or difficult-to-control cardiac arrhythmias. * Fever (body temperature ≥ 37.5°C) at the time of assessment. * Hypertension (blood pressure ≥ 130/80 mmHg) at the time of assessment. Primary Caregiver Criteria: \- Unable to be present to perform the intervention according to the study protocol.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Critical illness Critically ill patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Investigación del Instituto Nacional de Enfermedades Respiratorias

    RECRUITING

    Mexico City, Mexico City, 14080, Mexico

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