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NCT Number: NCT07163247

Effectiveness of Pet-Robotic Intervention 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.

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Key information

Conditions

Spontaneous Breathing Trial in ICU Anxiety Disorders Mental Disorders Spontaneous Breathing Trial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Chia-Hui Chen, PhD

CONTACT

[email protected]

+886-2-23123456 ext. 288438

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic pet (PARO) companionship

Behavioral

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

Primary outcomes

  1. Behavioral responses

    Time frame: 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.

    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).

  2. Subjective Psychological response

    Time frame: 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.

    Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).

  3. Objective Psychological Response

    Time frame: During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Crying or anger for more than five minutes (yes/no).

Secondary outcomes

  1. Signs of respiratory distress - heart rate

    Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Average heart rate measured in beats per minute (bpm).

  2. Signs of respiratory distress - blood pressure

    Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Average blood pressure measured in millimeters of mercury (mmHg).

  3. Signs of respiratory distress - respiratory rate

    Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Average respiratory rate measured in breaths per minute.

  4. Signs of respiratory distress - oxygen saturation

    Time frame: Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Average peripheral oxygen saturation measured in percent.

  5. Spontaneous breathing trial outcome

    Time frame: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Completion of spontaneous breathing trial (Yes/No).

  6. Duration of spontaneous breathing trial

    Time frame: After each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    Total duration of completed spontaneous breathing trial measured in minutes.

  7. Adverse events

    Time frame: From Day 1 of measurement until extubation, intensive care unit discharge, or early termination.

    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.

  8. Extubation within 24 hours

    Time frame: Within 24 hours from Day 1 of measurement.

    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.

  9. Experience of using robotic pet

    Time frame: 3 days after extubation.

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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