Therapeutic Robots for Alleviating ICU Stress in Children

NCT ID: NCT06854562

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2027-12-31

Brief 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?

Detailed Description

Children and adolescents in the intensive care unit (ICU) often find themselves in a confined, lonely environment due to changes in their health status. Their cognitive and self-concept development is not yet mature, making them prone to developing defense mechanisms and suppressing emotions. This can lead to noncompliance with treatment in an attempt to regain a sense of control, which further triggers negative emotions and affects their condition. Therapeutic robots, through human-robot interaction and a cute appearance, help alleviate stress and improve positive emotions by providing companionship and interaction. However, there is currently a lack of research on the effectiveness of therapeutic robots in ICU settings for hospitalized children and adolescents, which motivates this study. This research aims to explore the effectiveness of using therapeutic robots to alleviate the hospitalization stress of school-age children and adolescent patients in the ICU. The study will be conducted at the pediatric ICU of a medical center in northern Taiwan, and participants will include 8 to 18-year-old school-age children and adolescents who are hospitalized in the ICU. Participants will be randomly assigned into the experimental group, control group, and comparison group. The experimental group will use the therapeutic robot PARO as an intervention strategy, the control group will use a stuffed seal, and the comparison group will receive standard care. During the study, the Multidimensional Anxiety Scale for Children, the Children's Depression Inventory, and the Positive and Negative Emotion Scale will be used to measure the stress response of the three groups before the intervention, after the intervention, and before discharge from the ICU. Semi-structured interviews will be conducted using the triangulation method. Quantitative data will be analyzed using covariance analysis and generalized estimating equations, while qualitative data will be analyzed using content analysis. This study aims to develop an intervention measure to alleviate hospitalization stress in children in the ICU and evaluate its effectiveness. It is expected that through the interactive communication concept of the therapeutic robot, the social abilities of school-age children and adolescents will be enhanced, leading to an improvement in their positive emotional expression and promoting their psychological health.

Conditions

Pediatric Intensive Care Units

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1: Robot Seal Therapy

Arm 1 (Robot Seal Therapy):

Description: Children in this group will interact with a therapeutic robot seal designed to alleviate stress and provide emotional comfort. The robot seal will be used as a companion during their stay in the Pediatric Intensive Care Unit (PICU) to reduce feelings of anxiety and stress.

Group Type: EXPERIMENTAL

Therapeutic Robot Intervention

Intervention Type: BEHAVIORAL

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.

Arm 2: Toy Seal Therapy

Arm 2 (Toy Seal Therapy):

Description: Children in this group will engage with a toy seal as a comforting object. The toy seal will be used to help children cope with the hospital environment and reduce stress during their PICU stay.

Group Type: EXPERIMENTAL

Toy Seal Intervention

Intervention Type: BEHAVIORAL

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.

Arm 3: Standard Care

Arm 3 (Standard Care):

Description: Children in this group will receive standard care and routine interventions provided by healthcare professionals in the PICU without the use of additional therapeutic devices.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Robot Seal Therapy

Eligibility Criteria

Inclusion Criteria

1. Patients admitted to the intensive care unit (ICU).

2. Age range for enrollment is 8 to 18 years.

3. Able to stay awake and respond.

4. Able to communicate in Mandarin or Taiwanese.

5. Have been informed and have agreed to participate in the study.

Exclusion Criteria

1. Patients with a pacemaker.

2. Patients who require isolation according to hospital infection control regulations.

3. Patients with wounds that continue to ooze under the gauze covering.

4. Patients experiencing vomiting symptoms within the past 24 hours.

5. Patients assessed by a physician to be in a life-threatening condition.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yin-Yi Ke

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chi-Wen Chen, PhD

Role: CONTACT

chiwenchen@ym.edu.tw

02-28267348

Facility Contacts

Ke Yin-Yi, Master's

Role: primary

yinyi.ns12@nycu.edu.tw

0988992850

Other Identifiers

2025-02-017C

Identifier Type: -

Identifier Source: org_study_id