Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients
NCT ID: NCT07163247
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-09-30
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic pet (PARO) companionship
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.
Robotic pet (PARO) companionship
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.
Standard care
Participant in this arm will receive standard care.
No interventions assigned to this group
Interventions
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Robotic pet (PARO) companionship
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Facility Contacts
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Other Identifiers
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202505120RINC
Identifier Type: -
Identifier Source: org_study_id
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