Robotic Dog Intervention on Emotional Well-Being and Quality of Life

Официальное название

Effectiveness and Feasibility of a Robotic Dog Intervention on Emotional Well-Being and Quality of Life in Pediatric Patients With Hematological Malignancies Undergoing HSCT

Обзор

The hematopoietic stem cell transplantation (HSCT) process imposes a substantial psychological burden, leading to impaired emotional well-being due to intensive treatment, isolation, and immunosuppression. Patients often experience social withdrawal, loneliness, and loss of control, which may result in persistent anxiety, depressive symptoms, and reduced quality of life (QoL) if unaddressed. This study aims to evaluate the effectiveness, feasibility, and acceptability of an AI-powered robotic dog in improving emotional well-being and QoL in pediatric patients undergoing HSCT.

Подробное описание

Pediatric patients undergoing hematopoietic stem cell transplantation (HSCT) experience substantial psychological burden related to intensive treatment, protective isolation, prolonged hospitalization, and immunosuppression. Anxiety, emotional distress, loneliness, and reduced quality of life are common during the post-transplant inpatient period. However, infection control precautions and isolation procedures may limit access to traditional psychosocial support interventions in HSCT settings.

Technology-assisted interventions, particularly social robots, have emerged as promising approaches for supporting emotional well-being in pediatric healthcare environments. AI-powered robotic companion devices may provide interactive engagement, emotional comfort, and opportunities for play during prolonged hospitalization while remaining compatible with infection control requirements.

This pilot randomized controlled study aims to evaluate the effectiveness, feasibility, and acceptability of an AI-powered robotic dog intervention in improving emotional well-being and quality of life in pediatric patients undergoing HSCT.

Вмешательства

• Другое AIBO
  AIBO is an AI-powered interactive robot dog that engages children through play and touch-based interactions, including responding to petting, interacting with a ball, and making simple gestures. Using visual, auditory, and tactile sensing, AIBO enables spontaneous, child-centered interactions, expressing emotions through eye color changes, tail movements, and vocalizations, while gradually developing more adaptive behaviors through repeated interactions (weight: \~2.2 kg; dimensions: 180 × 293 ×

Первичные конечные точки

• Change in Positive and Negative Affect [Срок оценки: Baseline (Day 1, before intervention initiation) and weekly assessments during the intervention period at Weeks 2, 3, and 4.]
• Change in Emotional Well-being [Срок оценки: Baseline (Day 1, before intervention initiation) and weekly assessments during the intervention period at Weeks 2, 3, and 4.]
• Change in Health-Related Quality of Life [Срок оценки: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).]

Критерии участия

Критерии включения

• Pediatric patients aged 8-15 years
• Diagnosed with a hematological malignancy and undergoing hematopoietic stem cell transplantation
• Hospitalized in a protective isolation room during the post-transplant inpatient period
• Expected to remain hospitalized under isolation for approximately 30 days post-transplant
• Able to understand and respond to Turkish-language self-report questionnaires
• Clinically stable and deemed eligible for participation by the treating clinical team
• Able to interact with the robotic dog at a basic functional level

Критерии исключения

• Severe cognitive impairment or neurodevelopmental conditions preventing meaningful interaction or self-report
• Acute neurological conditions, delirium, or severe psychiatric crisis (e.g., acute agitation, suicidal ideation)
• Requirement for intensive care, invasive ventilation, or a clinically unstable condition
• Severe visual, hearing, or motor impairments that prevent interaction with the robotic dog
• Additional infection control restrictions prevent the placement or use of the robotic dog in the isolation room
• Anticipated early discharge, transfer, or inability to complete follow-up assessments
• Severe fear, intolerance, or refusal to interact with robotic or electronic devices

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607379 · KOCUNIVR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗