Effectiveness of Pet-Robotic Intervention in Intensive Care Unit Patients

NCT ID: NCT07163247

Last Updated: 2025-09-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spontaneous Breathing Trial in ICU Spontaneous Breathing Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Robotic pet (PARO) companionship

Intervention Type 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.

Standard care

Participant in this arm will receive standard care.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PARO@ICU

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chia-Hui Chen, PhD

Role: primary

+886-2-23123456 ext. 288438

Other Identifiers

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202505120RINC

Identifier Type: -

Identifier Source: org_study_id

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