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

NCT07761364 | Recruiting DMC

• 1 other identifier: C23-26
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Critically Ill Patients

Keywords

Intensive Care Unit; Critical Illness; Critically Ill Patients; Primary Caregiver; Family Caregive; Therapeutic Touch; Physical Contact; Human Touch; Physiological Parameters; Physiological Response; Heart Rate; Blood Pressure; Respiratory Rate; Oxygen Saturation; Critical Care Nursing; Patient-Centered Care

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate

  Heart rate, expressed as beats per minute (bpm), measured using a bedside multiparameter monitor through cutaneous electrodes. Changes in heart rate will be assessed before, during, and after the intervention.

  10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.

Secondary Outcomes (5)

• Change in Systolic Blood Pressure

  10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

• Change in Diastolic Blood Pressure

  10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

• Change in Respiratory Rate

  10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

• Change in Oxygen Saturation

  10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

• Change in Body Temperature

  10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

Study Arms (2)

Intervention

EXPERIMENTAL

Therapeutic physical contact provided by their primary caregiver

Other: Standardized therapeutic physical contact

Standard Care Without Therapeutic Contact

NO INTERVENTION

Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.

Interventions

Standardized therapeutic physical contact OTHER

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.

Also known as: Physical contact

Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma del Estado de Mexico: lead

Study Sites (1)

Investigación del Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel Álvarez-Solorza, RN, PhD

  Universidad Autonoma del Estado de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Álvarez-Solorza, Dr.

CONTACT

+52 1 7222231161; ialvarezs@uaemex.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Researcher

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning after publication of the primary study results with no predetermined end date.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents will be available upon reasonable request to the principal investigator. Access will be granted to researchers with a methodologically sound research proposal following review and approval by the research team and in accordance with ethical and institutional requirements. Data will be shared in a secure manner and only for approved research purposes.

Locations

ME (1)