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

N/ANot Yet RecruitingNCT07607379

Koç University28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Interventions

AIBOOTHER

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 × 305 mm)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in Positive and Negative Affect

Emotional affect will be assessed using the Positive and Negative Affect Schedule for Children (PANAS-C). The scale evaluates positive and negative emotional states experienced by pediatric patients undergoing hematopoietic stem cell transplantation during the inpatient isolation period.

Time frame: Baseline (Day 1, before intervention initiation) and weekly assessments during the intervention period at Weeks 2, 3, and 4.

Change in Emotional Well-being

Children's emotional well-being will be assessed using the Stirling Children's Well-being Scale. The scale evaluates positive emotional functioning, interpersonal relationships, and overall psychological well-being in children undergoing hematopoietic stem cell transplantation during the inpatient isolation period.

Time frame: 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

Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale consists of 23 items evaluating physical, emotional, social, and school functioning in children and adolescents. Items are rated on a 5-point Likert scale, with higher scores indicating better health-related quality of life.

Time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).