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Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver (CARE-ICU)

10 agosto 2026 aggiornato da: Liliana Argueta-Figueroa, Universidad Autonoma del Estado de Mexico

Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical Trial

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a randomized, controlled, parallel-group, double-blind clinical trial designed to evaluate the effect of therapeutic contact provided by the primary caregiver on physiological parameters in adult intensive care unit (ICU) patients. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (therapeutic contact) or the control group (no therapeutic contact) using block randomization generated by an independent external advisor. Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed, tamper-evident envelopes.

Sample size was calculated for the comparison of means between two independent groups using a 95% confidence level (α = 0.05), 80% statistical power (β = 0.20), a standard deviation of 7.6, and a minimum clinically meaningful difference of 5 units. The estimated sample size was 36 participants per group. After adjustment for an anticipated 10% attrition rate, a total of 80 participants (40 per group) will be enrolled.

Physiological outcomes include heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation, and body temperature. Measurements will be obtained using a bedside multiparameter monitor and recorded on a standardized physiological data collection form. Equipment calibration will be verified before each measurement. Outcomes will be assessed 10 minutes before the caregiver visit, 10 minutes after the start of the visit, and 10 minutes after completion of the visit.

Changes in physiological outcomes will be calculated as the difference between baseline measurements and subsequent assessments. Data analysis will be performed using IBM SPSS Statistics Version 29.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, according to data distribution. Categorical variables will be summarized using frequencies and percentages. Normality will be evaluated using the Kolmogorov-Smirnov test. For each physiological outcome, change scores will be calculated by subtracting baseline values from measurements obtained during and after the caregiver visit. Mean changes between the intervention and control groups will be compared using the independent-samples t-test or the Mann-Whitney U test, as appropriate. Effect sizes will be estimated using Cohen's d. Statistical significance will be established at p < 0.05. The study was approved by the Research Ethics Committee of the Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas". The trial will be conducted in accordance with the Declaration of Helsinki and applicable Mexican regulations governing health research. Written informed consent will be obtained from all participants or their legally authorized representatives before enrollment. Adverse events will be documented and reported to the institutional ethics committee and ClinicalTrials.gov according to applicable regulatory requirements.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Isabel Álvarez-Solorza, Dr.
  • Numero di telefono: 8038 +52 1 7222231161
  • Email: ialvarezs@uaemex.mx

Luoghi di studio

  • Messico
    • Mexico City
      • Mexico City, Mexico City, Messico, 14080
        • Reclutamento
        • Investigación del Instituto Nacional de Enfermedades Respiratorias
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
Therapeutic physical contact provided by their primary caregiver
Altro: 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.

Altri nomi:
  • Physical contact
Nessun intervento: Standard Care Without Therapeutic Contact
Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Heart Rate
Lasso di tempo: 10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Systolic Blood Pressure
Lasso di tempo: 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.
Systolic blood pressure, defined as the maximum arterial pressure during cardiac contraction, measured in millimeters of mercury (mmHg). Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
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
Lasso di tempo: 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.
Diastolic blood pressure, defined as the minimum arterial pressure during cardiac relaxation, measured in millimeters of mercury (mmHg). Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
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
Lasso di tempo: 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.
Respiratory rate, defined as the number of breaths per minute (breaths/min), measured using a bedside multiparameter monitor through cutaneous electrodes.
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
Lasso di tempo: 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.
Oxygen saturation, defined as the percentage of arterial hemoglobin saturated with oxygen (SpO₂), measured using a pulse oximeter placed on the patient's finger under conditions free of movement interference.
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
Lasso di tempo: 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.
Body temperature, defined as the degree of body heat expressed in degrees Celsius (°C), measured in the axillary region using a temperature probe connected to a bedside multiparameter monitor.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Autonoma del Estado de Mexico

Investigatori

  • Investigatore principale: Isabel Álvarez-Solorza, RN, PhD, Universidad Autonoma del Estado de Mexico

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2026

Completamento primario (Stimato)

31 agosto 2026

Completamento dello studio (Stimato)

31 agosto 2026

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2026

Primo Inserito (Effettivo)

12 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C23-26

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data (IPD) may be made available upon reasonable request to the principal investigator, subject to approval by the research team and ethics committee and in accordance with applicable regulation

Periodo di condivisione IPD

Beginning after publication of the primary study results with no predetermined end date.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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