RecruitingNot ApplicableNCT06854562

Therapeutic Robots for Alleviating ICU Stress in Children

The Effectiveness of Using a Therapeutic Robot to Alleviate Hospitalization Stress Among Children in Intensive Care Units: A Randomized Controlled Trial


Sponsor

National Yang Ming Chiao Tung University

Enrollment

105 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is: (a) to examine the changes in anxiety, depression symptoms, and positive/negative emotions before and after the intervention, as well as before discharge from the intensive care unit (ICU) in the experimental group (using the therapeutic robot PARO), the control group (using a stuffed seal), and the comparison group (receiving standard care). (b) To compare the effectiveness in relieving anxiety, depression symptoms, and positive/negative emotions among the experimental group, control group, and comparison group for ICU pediatric and adolescent patients in the school-age period. The research questions addressed in this study are: 1. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the experimental group? 2. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the control group? 3. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the comparison group? 4. What is the effectiveness in reducing anxiety after the intervention among the experimental group, control group, and comparison group? 5. What is the effectiveness in alleviating depression symptoms after the intervention among the experimental group, control group, and comparison group? 6. What is the effectiveness in reducing negative emotions and increasing positive emotions after the intervention among the experimental group, control group, and comparison group?


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria5

  • Patients admitted to the intensive care unit (ICU).
  • Age range for enrollment is 8 to 18 years.
  • Able to stay awake and respond.
  • Able to communicate in Mandarin or Taiwanese.
  • Have been informed and have agreed to participate in the study.

Exclusion Criteria5

  • Patients with a pacemaker.
  • Patients who require isolation according to hospital infection control regulations.
  • Patients with wounds that continue to ooze under the gauze covering.
  • Patients experiencing vomiting symptoms within the past 24 hours.
  • Patients assessed by a physician to be in a life-threatening condition.

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Interventions

BEHAVIORALTherapeutic Robot Intervention

This intervention involves the use of a therapeutic robot seal, PARO, to interact with pediatric patients in the Pediatric Intensive Care Unit (PICU). The intervention is designed to alleviate stress and anxiety in children during their hospital stay. The robot provides emotional support by engaging in 30-minute sessions, where children can interact with the robot, give it a name, and express their emotions. The therapeutic interaction is repeated twice on consecutive days.

BEHAVIORALToy Seal Intervention

In this group, children interact with a plush toy seal. The plush seal is used to provide emotional comfort and reduce anxiety during their stay in the PICU. The interaction happens over two consecutive days for 30 minutes per session.

BEHAVIORALStandard Care

Children in this group will receive standard care and routine interventions provided by healthcare professionals in the PICU, without the use of therapeutic robots or plush toys.


Locations(1)

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

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NCT06854562