Effects of Therapeutic Contact by Primary Caregivers on Vital Signs in Adults in Intensive Care Units A Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating how physical contact with a primary caregiver affects physiological responses in adult patients admitted to intensive care units ICUs. This randomized, controlled, double-blind clinical trial focuses on adults aged 18 to 59 who are hospitalized in an ICU, aiming to understand changes in heart rate, blood pressure, respiratory rate, oxygen saturation, and body temperature during and after caregiver visits. Participants will be randomly assigned to one of two groups an intervention group receiving standardized therapeutic physical contact from their primary caregiver, and a control group receiving standard ICU care without this contact. The therapeutic contact involves a 20-minute visit where caregivers provide gentle massages and positive interaction following a specific protocol. Caregivers receive training before the visit, and feedback is collected afterward. During the study, physiological measurements will be taken 10 minutes before the caregiver visit, during the visit 10 minutes after it starts, and 10 minutes after it ends using bedside monitors. Data will be analyzed to compare changes between groups. The study includes written informed consent and ongoing safety monitoring, with adverse events reported to ethics committees. The trial is sponsored by Universidad Autonoma del Estado de Mexico and will run until August 2026.

Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver