臨床研究等提出・公開システム

Investigation of the effect of perioperative stress reduction in pediatric patients by introducing artificial intelligence Aibo.

Evaluation of stress reduction using Aibo before and after surgery in children

Suda Kazuto

Department of Pediatric General and Urogenital Surgery, Juntendo University School of Medicine, Tokyo, Japan

2 Chome-1-1 Hongo, Bunkyo City, Tokyo

kdsuda@juntendo.ac.jp

Suda Kazuto

Juntendo University School of Medicine, Tokyo, Japan

Juntendo OG Building, 3-3-13 Hongo, Bunkyo-ku, Tokyo, Japan

+81-9083187008

kdsuda@juntendo.ac.jp

Recruiting

Jan. 07, 2026

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

supportive care

Eligible participants will be hospitalized pediatric patients who are considered capable of cooperating with the study procedures, including saliva collection and wearing an autonomic nervous system monitor on the anterior chest, and who are deemed suitable for participation based on the study overview. Patients aged 1 year or older who have received a sufficient explanation of the study and provided informed consent based on adequate understanding will be included.
The target sample size is set at a total of 80 participants, comprising 40 patients in the intervention group and 40 in the control group. The study will employ a monthly alternating design, with periods during which Aibo is introduced and periods during which Aibo is not present. Patients who do not interact with Aibo will serve as the control group. This design was adopted to avoid potential concerns of unfairness from patients or guardians that might arise if control participants were selected during periods when Aibo is present on the ward but interaction is restricted.

Participants will be considered ineligible if the principal investigator judges them to be unsuitable for participation, even if they do not meet any of the predefined exclusion criteria. Such cases include, but are not limited to, patients younger than 1 year of age or those with conditions such as cerebral palsy, in whom cooperation with saliva collection and placement of an autonomic nervous system monitor on the anterior chest is not feasible. Conversely, patients who do not fall under any of the exclusion criteria and are deemed capable of cooperating with the study procedures will be considered eligible.

Both

pediatric surgical diseases

(1) Introduction of Aibo-assisted therapy during the perioperative period (preoperative phase).
(2) Assessment of pediatric patients during the perioperative period using self-reported evaluations, salivary stress hormone levels, and measurements of autonomic nervous system balance.
(3) Evaluation of oxidative stress balance in pediatric patients during the perioperative period using the REDOXLIBRA device.
(4) Analysis of changes in the measurements described in (1), (2), and (3) according to the presence or absence of Aibo-assisted therapy.

By integrating changes in stress hormone levels, autonomic nervous system balance, and real-time assessment of oxidative stress balance using saliva, and correlating these data with clinical parameters, this study aims to clarify whether perioperative stress in pediatric patients with surgical conditions is alleviated through interaction with Aibo. Furthermore, this approach is expected to identify specific clinical parameters that are most strongly influenced by Aibo-assisted intervention.

Aibo

perioperative stress Aibo cortisol autonomic nervous system balance

Workflow for the introduction of Aibo
Upon admission, the physician in charge of this study will provide an explanation of the study and obtain informed consent from the patient and/or their legal guardian on the ward.
On the day of admission, patients will interact with Aibo for 30 minutes in the playroom of Ward 10A or 10B.
For patients who are able to communicate verbally, a medical procedure preparation program will also be incorporated, in which the patient experiences simulated medical procedures, such as auscultation or injections, together with Aibo.
Members of the research team, including medical staff and psychologists, will supervise and manage Aibo while facilitating interaction between the patient and Aibo.

Self-report assessment
Self-report assessment will be conducted using a face scale routinely employed in clinical practice. Healthcare professionals will evaluate perioperative pain and discomfort in pediatric patients based on positive and negative words and expressions expressed by the patient.

Biological approach
Measurement of salivary and serum hormone levels
The following biomarkers will be measured: cortisol, chromogranin A, and oxytocin.

Assessment of the acute effects of Aibo:
Saliva samples will be collected immediately before and after interaction with Aibo.

Comparison of Aibo effects before and after surgery (using serum):
Serum samples will be obtained from blood specimens collected as part of routine clinical care and retrieved from the clinical laboratory as follows:

Preoperative: samples collected during routine outpatient preoperative examinations

Postoperative: samples collected immediately after surgery and on postoperative days 1 and 3

Autonomic nervous system monitoring
An autonomic nervous system monitor will be attached before the patient enters the playroom and removed when the patient leaves after interacting with Aibo.
Autonomic nervous system balance will be evaluated by analyzing the LF/HF ratio and heart rate variability.

+81-338133111

Nov. 24, 2023

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