Therapeutic Robots for Alleviating ICU Stress in Children

NCT06854562 | Recruiting

• 1 other identifier: 2025-02-017C
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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. 1.What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the experimental group?
2. 2.What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the control group?
3. 3.What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the comparison group?
4. 4.What is the effectiveness in reducing anxiety after the intervention among the experimental group, control group, and comparison group?
5. 5.What is the effectiveness in alleviating depression symptoms after the intervention among the experimental group, control group, and comparison group?
6. 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

Keywords

Therapeutic Robot; Pediatric Intensive Care Unit (PICU); School-age Children; Adolescents; Hospitalization Stress Response

Outcome Measures

Primary Outcomes (3)

• Anxiety

  The Multidimensional Anxiety Scale for Children will be used to measure the patient's anxiety. This scale includes multiple dimensions, typically assessing emotional, behavioral, and physiological responses. Each dimension consists of several questionnaire items, rated on a Likert scale with a range from 0 to 3, and includes a total of 39 items. The total score correlates with the level of anxiety, with higher scores indicating higher anxiety. This scale provides a comprehensive assessment of the child's anxiety from multiple perspectives.

  Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).

• Depression

  The Children's Depression Inventory (CDI) - Short Version is a screening tool used to assess the level of depression in children and adolescents. It consists of a shortened set of items that evaluate emotional, behavioral, and cognitive symptoms related to depression. The scale typically includes 12 items, each rated on a Likert scale, with higher scores indicating more severe symptoms of depression. The tool provides a quick yet effective measure of depressive symptoms in children, helping to identify those who may need further evaluation or intervention.

  Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).

• Positive and Negative Affect

  The Positive and Negative Affect Schedule (PANAS) is a psychological tool used to measure both positive and negative emotional states in individuals. It consists of two subscales: one assessing positive affect (PA) and the other assessing negative affect (NA). Each subscale includes a list of emotional terms, with participants rating the extent to which they have experienced these emotions during a specified time frame (e.g., the past week, day, or moment). The items are rated on a Likert scale, usually ranging from 1 (very slightly or not at all) to 5 (extremely). Higher scores on the positive affect subscale indicate a higher level of positive emotions, while higher scores on the negative affect subscale indicate a higher level of negative emotions. PANAS is commonly used in both research and clinical settings to assess mood, emotional well-being, and emotional responses to various stimuli or interventions.

  Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).

Study Arms (3)

Arm 1: Robot Seal Therapy

EXPERIMENTAL

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.

Behavioral: Therapeutic Robot Intervention

Arm 2: Toy Seal Therapy

EXPERIMENTAL

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.

Behavioral: Toy Seal Intervention

Arm 3: Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Care

Interventions

Therapeutic Robot Intervention 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.

Also known as: Robot Seal Therapy

Arm 1: Robot Seal Therapy

Toy Seal Intervention 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 2: Toy Seal Therapy

Standard Care 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.

Arm 3: Standard Care

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yin-Yi Ke

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Wen Chen, PhD

CONTACT

02-28267348; chiwenchen@ym.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)