Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

NCT07163247 | Recruiting

• 1 other identifier: 202505120RINC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spontaneous Breathing Trial in ICU; Spontaneous Breathing Trial

Keywords

spontaneous breathing trials; Pet-robotic intervention; anxiety; Robot assisted intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Signs of respiratory distress - heart rate

  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

  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

  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

  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

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

Study Arms (2)

Robotic pet (PARO) companionship

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Participant in this arm will receive standard care.

Interventions

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.

Also known as: PARO@ICU

Robotic pet (PARO) companionship

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

TW (1)