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

NCT07761364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Critically Ill Patients

Interventions

OTHER

Standardized therapeutic physical contact

During the pre-visit phase (30 minutes), caregivers will receive information about the study, patient's condition, infection control procedures, and training on the standardized contact protocol. During the visit phase (20 min), the caregiver will greet the patient in a customary manner (1 min); provide a gentle massage to the dorsal surface of the hand while discussing positive events of the day (6 min); gently touch the patient's forehead with the fingertips while recalling pleasant memories (3 min); gently massage the patient's cheek using the fingertips while providing encouraging and positive messages (3 minutes); massage the palm of the patient's hand using circular movements while discussing goals to be achieved after hospital discharge (4 min); and holding the patient's hand and expressing wishes for recovery and discharge (3 min). Following the visit, caregivers will be given the opportunity to share observations, comments, and feedback regarding the intervention experience.

Sponsors & Collaborators

  • Universidad Autonoma del Estado de Mexico

    lead OTHER

Principal Investigators

  • Isabel Álvarez-Solorza, RN, PhD · Universidad Autonoma del Estado de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761364 on ClinicalTrials.gov