Pediatric Intensive Care UnitsNYMCTUNCT06854562
Therapeutic Robots for Alleviating ICU Stress in Children
A study testing Therapeutic Robot Intervention and Toy Seal Intervention in people with Pediatric Intensive Care Units, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Intensive Care Units
- What is being tested?
- Therapeutic Robot Intervention and Toy Seal Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou District, 11217
Ke Yin-Yi, Master's, 0988992850, yinyi.ns12@nycu.edu.tw
About this study
Official title: The Effectiveness of Using a Therapeutic Robot to Alleviate Hospitalization Stress Among Children in Intensive Care Units: A Randomized Controlled Trial
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:
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the experimental group?
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the control group?
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the comparison group?
- What is the effectiveness in reducing anxiety after the intervention among the experimental group, control group, and comparison group?
- What is the effectiveness in alleviating depression symptoms after the intervention among the experimental group, control group, and comparison group?
- What is the effectiveness in reducing negative emotions and increasing positive emotions after the intervention among the experimental group, control group, and comparison group?
Read the 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
- Being tested
- Therapeutic Robot Intervention, Toy Seal Intervention, Standard Care
- Keywords
- Therapeutic Robot, Pediatric Intensive Care Unit (PICU), School-age Children, Adolescents, Hospitalization Stress Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Robot InterventionBehavioural
Also called Robot Seal Therapy
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.
Toy Seal InterventionBehavioural
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.
Standard CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start14 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin-Yi Ke, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854562
- Sponsor's protocol ID
- 2025-02-017C
- Acronym
- NYMCTU
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using a Therapeutic Robot to Alleviate Hospitalization Stress Among Children in Intensive Care Units: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06854562
- Acronym / sponsor ID
- NYMCTU / 2025-02-017C
- Conditions
- Pediatric Intensive Care Units
- Keywords
- Therapeutic Robot, Pediatric Intensive Care Unit (PICU), School-age Children, Adolescents, Hospitalization Stress Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the experimental group?
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the control group?
- What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the comparison group?
- What is the effectiveness in reducing anxiety after the intervention among the experimental group, control group, and comparison group?
- What is the effectiveness in alleviating depression symptoms after the intervention among the experimental group, control group, and comparison group?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Robot Seal Therapy | Experimental | Behavioral: Therapeutic Robot InterventionArm 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. |
| Arm 2: Toy Seal Therapy | Experimental | Behavioral: Toy Seal InterventionArm 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. |
| Arm 3: Standard Care | Active comparator | Behavioral: Standard CareArm 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Robot InterventionAlso: Robot Seal TherapyThis 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. | Behavioural | Arm 1: Robot Seal Therapy |
| Toy Seal InterventionIn 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. | Behavioural | Arm 2: Toy Seal Therapy |
| Standard CareChildren 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. | Behavioural | Arm 3: Standard Care |
Primary outcome
Anxiety
Time frame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
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.
Depression
Time frame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
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.
Positive and Negative Affect
Time frame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Pediatric Intensive Care Units
RecruitingObservational study
A Korean Point Prevalence Study of Acute Rehabilitation for Kids in the PICU (PARK-PICU)
Pediatric Intensive Care Units
Not yet recruitingObservational study
Impact of Sedation Practices on Clinical Outcomes Among Mechanically Ventilated Children
Mechanically Ventilated Children Admitted to the Pediatric Intensive Care Unit
RecruitingObservational study
FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids
Acute Kidney Injury, Renal Replacement Therapy
Recruiting
Comfort Intervention in PICU Children
Pediatric Intensive Care Unit, Comfort
RecruitingObservational study
Asia Pediatric Intensive Care Epidemiology and Outcomes Study
Pediatrics, Intensive Care Unit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yin-Yi Ke principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Robot Intervention and Toy Seal Intervention in people with Pediatric Intensive Care Units, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Wen Chen, PhD (02-28267348, chiwenchen@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.