Therapeutic Robots for Alleviating ICU Stress in Children
NCT06854562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2025-09-22
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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