Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Careg… (NCT07761364) | Clinical Trial Compass
RecruitingNot Applicable
Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver
Mexico80 participantsStarted 2026-08-01
Plain-language summary
Patients admitted to intensive care units are exposed to multiple environmental and clinical factors that may affect their physiological responses. This randomized controlled trial aims to evaluate the effect of physical contact with the primary caregiver on physiological parameters in adult patients hospitalized in an intensive care unit.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Heart Rate
Timeframe: 10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.