Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

Effectiveness of Using Pet-Robotic Intervention to Enhance Spontaneous Breathing Trial Success in Intensive Care Unit Patients

This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Breathing Trial; Spontaneous Breathing Trial in ICU
• Intervention / Treatment: Behavioral: Robotic pet (PARO) companionship

Detailed Description

This study aims to investigate the effectiveness of pet robotic intervention during spontaneous breathing trials in adult patients admitted to medical intensive care units. The study explores whether this intervention can alleviate patients' anxiety during the weaning process, as well as enhance successful spontaneous breathing trials and facilitate further extubation.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chia-Hui Chen, PhD; Phone Number: 288438 +886-2-23123456; Email: cherylchen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older with clear consciousness.
• Mechanical ventilation for more than 72 hours.
• Previously failed the first spontaneous breathing trial and is clinically ready to undergo a second spontaneous breathing trial.

Exclusion Criteria:

• Multidrug-resistant organism infection.
• Requiring airborne infection isolation precautions (e.g., COVID-19).
• Immunodeficiency (absolute neutrophil count < 500 cells/mL).
• Richmond Agitation-Sedation Scale (RASS) less than -1.
• Patient with a tracheostomy.
• Subjects with implanted cardiac devices (e.g., permanent pacemaker, implantable cardioverter defibrillators)
• Known allergy to the fur of the robotic pet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic pet (PARO) companionship; Participants will receive companionship from a robotic baby seal pet (PARO) during their spontaneous breathing trials. The intervention will be administered continuously throughout the entire duration of the spontaneous breathing trials period or until the participant meets predefined early termination criteria.	Behavioral: Robotic pet (PARO) companionship; The intervention is composed of the following components: Duration: Robotic pet companionship lasting 30-120 minutes, depending on clinical goals during each spontaneous breathing trial (SBT). Preparation and interaction: PARO is introduced 30 minutes before each SBT to establish emotional connection. Study staff will briefly introduce its interactive features, including responding to stroking, gentle tapping, head movements, and eye blinking. Participants may interact freely with PARO during the intervention. Assessment: Outcome measurements are conducted during the intervention. If extubated successfully, a semi-structured interview is conducted three days later. Early termination: The intervention is stopped if the participant becomes clinically unsuitable for further SBTs or experiences a serious adverse event (e.g., device dislodgement). Additional information: After each SBT, PARO is sterilized and stored in a sealed container in the patient's room.; Other Names: PARO@ICU
No Intervention: Standard care; Participant in this arm will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral responses	Behavioral responses will be assessed using the Motor Activity Assessment Score (MAAS). Data will be analyzed as both continuous and categorical variables. Continuous variable: mean MAAS score (range 0-6). Categorical variables: Sedated (MAAS 0-2); Cooperative (MAAS = 3); Agitated (MAAS 4-6).	Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 until extubation, intensive care unit discharge, or early termination.
Subjective Psychological response	Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).	Baseline (within 30 minutes prior to each spontaneous breathing trial from Day 1), then every 30 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Objective Psychological Response	Crying or anger for more than five minutes (yes/no).	During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of respiratory distress - heart rate	Average heart rate measured in beats per minute (bpm).	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Signs of respiratory distress - blood pressure	Average blood pressure measured in millimeters of mercury (mmHg).	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Signs of respiratory distress - respiratory rate	Average respiratory rate measured in breaths per minute.	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Signs of respiratory distress - oxygen saturation	Average peripheral oxygen saturation measured in percent.	Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Spontaneous breathing trial outcome	Completion of spontaneous breathing trial (Yes/No).	After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Duration of spontaneous breathing trial	Total duration of completed spontaneous breathing trial measured in minutes.	After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Adverse events	All adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), as defined by Good Clinical Practice (GCP), will be recorded.	From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.
Extubation within 24 hours	Extubation is defined as removal of the endotracheal tube after the physician's evaluation and confirmation of readiness. Success is defined as removal of the tube within 24 hours and is measured as yes/no.	Within 24 hours from Day 1 of measurement.
Experience of using robotic pet	A semi-structured interview will be conducted with participants in the experimental arm. The interview will include the following four domains: Experiences with the spontaneous breathing trials.; Experiences with robotic pet companionship.; Perceived helpfulness of the robotic pet in alleviating anxiety.; Suggestions for future use of the robotic pet.	3 days after extubation.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 24, 2025
• First Submitted That Met QC Criteria: September 2, 2025
• First Posted (Estimated): September 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; spontaneous breathing trials; Pet-robotic intervention; Robot assisted intervention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 202505120RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No