Therapeutic Robots for Alleviating ICU Stress in Children

NCT06854562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-09-22

No results posted yet for this study

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?

Conditions

  • Pediatric Intensive Care Units

Interventions

BEHAVIORAL

Therapeutic 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.

BEHAVIORAL

Toy 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.

BEHAVIORAL

Standard 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.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    lead OTHER

Principal Investigators

  • Yin-Yi Ke · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854562 on ClinicalTrials.gov