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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard care | No Intervention | Participant in this arm will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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:
| 3 days after extubation. |