Using a friendly robotic seal to reduce ICU stress in children and teens
The Effectiveness of Using a Therapeutic Robot to Alleviate Hospitalization Stress Among Children in Intensive Care Units: A Randomized Controlled Trial
We will try a therapeutic robot (PARO) with children and teens aged 8–18 in the pediatric ICU to see if it reduces anxiety, depressive symptoms, and negative emotions compared with a stuffed seal or usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | National Yang Ming Chiao Tung University Academic / other |
| Locations | 1 site (Taipei, Beitou District) |
| Trial ID | NCT06854562 on ClinicalTrials.gov |
What this trial studies
This randomized intervention enrolls 8–18-year-olds admitted to the pediatric ICU at Taipei Veterans General Hospital and assigns them to one of three groups: PARO therapeutic robot, a stuffed seal control, or standard care. Emotional outcomes (anxiety, depressive symptoms, and positive/negative emotions) are measured before and after the intervention and again before ICU discharge. The researchers compare within-group changes and between-group differences to determine whether social interaction with PARO produces greater emotional benefit than a toy or routine care. Exclusion criteria include pacemakers, active isolation requirements, ongoing wound bleeding under dressings, recent vomiting, or physician-identified life-threatening conditions.
Who should consider this trial
Good fit: Children and adolescents aged 8–18 who are admitted to the pediatric ICU, are awake and able to respond, can communicate in Mandarin or Taiwanese, and have given informed assent/consent are ideal candidates.
Not a fit: Patients who require isolation, have a pacemaker, are actively bleeding under dressings, have recent vomiting, or are judged to be in life-threatening condition are excluded and would not be expected to benefit from the robot intervention.
Why it matters
Potential benefit: If successful, the robot could help reduce anxiety and negative emotions and improve mood and cooperation during pediatric ICU stays.
How similar studies have performed: PARO and similar therapeutic robots have shown mood and anxiety benefits in older adults and some pediatric settings, but controlled evidence in pediatric ICU populations is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei, Beitou District
- Taipei Veterans General Hospital — Taipei, Beitou District, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yin-Yi Ke — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Chi-Wen Chen, PhD
- Email: chiwenchen@ym.edu.tw
- Phone: 02-28267348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.