NCT07761364 Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver
| NCT ID | NCT07761364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Autonoma del Estado de Mexico |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-08-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Isabel Álvarez-Solorza, RN, PhD
PRINCIPAL INVESTIGATOR
Universidad Autonoma del Estado de Mexico
Frequently Asked Questions
Who can join the NCT07761364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07761364 currently recruiting?
Yes, NCT07761364 is actively recruiting participants. Contact the research team at ialvarezs@uaemex.mx for enrollment information.
Where is the NCT07761364 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07761364 clinical trial?
NCT07761364 is sponsored by Universidad Autonoma del Estado de Mexico. The principal investigator is Isabel Álvarez-Solorza, RN, PhD at Universidad Autonoma del Estado de Mexico. The trial plans to enroll 80 participants.