This study aims to develop a novel nursing intervention involving robotic pet companionship to reduce anxiety in patients undergoing spontaneous breathing trials.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGBehavioral 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.
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.
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.
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.
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.
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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.
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.
Spontaneous breathing trial outcome
Completion of spontaneous breathing trial (Yes/No).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. Experiences with the spontaneous breathing trials. 2. Experiences with robotic pet companionship. 3. Perceived helpfulness of the robotic pet in alleviating anxiety. 4. Suggestions for future use of the robotic pet.
Time frame: 3 days after extubation.