Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic pet (PARO) companionship
BehavioralThe 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Robotic pet (PARO) companionshipExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
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.2
Subjective Psychological response
Measured by using the Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety).
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.3
Objective Psychological Response
Crying or anger for more than five minutes (yes/no).
Time frame
During each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.Secondary outcomes
1
Signs of respiratory distress - heart rate
Average heart rate measured in beats per minute (bpm).
Time frame
Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.2
Signs of respiratory distress - blood pressure
Average blood pressure measured in millimeters of mercury (mmHg).
Time frame
Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.3
Signs of respiratory distress - respiratory rate
Average respiratory rate measured in breaths per minute.
Time frame
Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.4
Signs of respiratory distress - oxygen saturation
Average peripheral oxygen saturation measured in percent.
Time frame
Every 5 minutes during each spontaneous breathing trial from Day 1 of measurement until extubation, intensive care unit discharge, or early termination.Sponsors and contacts
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Source ClinicalTrials.gov