Robotic Dog Intervention on Emotional Well-Being and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-15
SponsorKoç University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AIBO
Other interventionAIBO 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)
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Standard care & Control Group CareNo intervention 0 interventions
Group B: Intervention Group (AIBO Group):Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 4.2
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 4.3
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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