Clinical trial NCT06854562: Therapeutic Robots for Alleviating ICU Stress in Children
Official title: The Effectiveness of Using a Therapeutic Robot to Alleviate Hospitalization Stress Among Children in Intensive Care Units: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Intensive Care Units
Keywords: Therapeutic Robot
Pediatric Intensive Care Unit (PICU)
School-age Children
Adolescents
Hospitalization Stress Response
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Anxiety
timeFrame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
measure: Depression
timeFrame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
measure: Positive and Negative Affect
timeFrame: Before the intervention, immediately after the intervention, and before discharge from the intensive care unit (ICU).
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yin-Yi Ke
role: PRINCIPAL_INVESTIGATOR
References: