Effects of a caregiver's physical contact on ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group trial compares standardized therapeutic physical contact from the patient’s primary caregiver to a control condition with no such contact in adult ICU patients. Participants are randomly assigned in a 1:1 ratio with allocation concealment, and outcomes are measured at three time points around the caregiver visit using bedside monitoring. The study focuses on physiological parameters such as heart rate, blood pressure, respiratory rate, oxygen saturation, and temperature to see if caregiver interaction affects these measures. Eligible patients are adults in the ICU for 24–48 hours with specific sedation and consciousness criteria, and their identified primary caregiver must participate under informed consent. The trial is conducted at the Instituto Nacional de Enfermedades Respiratorias with the Universidad Autonoma del Estado de Mexico as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigación del Instituto Nacional de Enfermedades Respiratorias
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Principal investigator: Isabel Álvarez-Solorza, RN, PhD — Universidad Autonoma del Estado de Mexico
• Study coordinator: Isabel Álvarez-Solorza, Dr.
• Email: ialvarezs@uaemex.mx
• Phone: +52 1 7222231161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

• Levetiracetam Dosing in Critically Ill on CRRT

  This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

  Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

• Respiratory Physiotherapy in Critically Ill Pneumonia Patients

  This study tests whether a structured breathing and chest therapy program can change inflammatory biomarkers in adults with pneumonia in the ICU compared to usual care.

  Recruiting Hospital H+ Queretaro · Querétaro · NCT07909616

• Immersive VR for improving upper limb function in critically ill ICU patients

  This trial tests whether fully immersive virtual reality training added to standard ICU rehabilitation can help improve upper limb strength and coordination in adults with ICU-acquired weakness.

  Recruiting National and Kapodistrian University of Athens · Athens, Attica · NCT07901855

• Cycling with immersive VR for ICU patients recovering from critical illness

  In this crossover study, critically ill adults in the ICU will try three 10-minute cycling sessions to see if an immersive VR environment motivates them more than cycling with no visuals or cycling while watching a route on a TV.

  Recruiting KU Leuven · Leuven · NCT07894146

• Factors Influencing Outcomes in ECMO and Impella Patients

  This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.

  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.