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

NCT07607379 | Not Yet Recruiting

• 1 other identifier: KOCUNIVR
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Emotional Well-being; Quality of Life; Pediatric Oncology

Keywords

technology; pediatric oncohematology; Hematological Malignancy; well-being; nurse

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Study Arms (2)

Standard care & Control Group Care

NO INTERVENTION

Participants in the control group will receive standard post-transplant inpatient care routinely provided in the HSCT unit. Standard care includes protective isolation procedures, restricted visitor access, routine clinical monitoring, and infection control practices during the inpatient transplantation period. Children are permitted to use personal electronic devices and other approved washable or disinfectable materials available within institutional infection control regulations. No structured psychosocial or technology-assisted intervention will be provided to the control group during the study period.

Intervention Group (AIBO Group):

EXPERIMENTAL

Participants assigned to the intervention group will receive standard post-transplant inpatient care in addition to a technology-assisted psychosocial support intervention during the inpatient isolation period following HSCT. The intervention will be implemented throughout the hospitalization period, and participants will be encouraged to engage with the device regularly during daily care routines. Baseline assessments will be performed within the first 24-48 hours after HSCT, and follow-up assessments will be conducted weekly for four weeks. Intervention adherence, feasibility indicators, and adverse events will be monitored throughout the study period. Infection control procedures will be applied according to institutional protocols.

Other: AIBO

Interventions

AIBO OTHER

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)

Intervention Group (AIBO Group):

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Eysan Savaş, PhD

CONTACT

+90 5068418841; eysansavas@gmail.com

Remziye Semerci, PhD

CONTACT

+90 535 0112821; remziyesemerci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No masking will be applied in this study due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and Research Assistant

Model Details: The study is designed as a single-center, randomized, controlled pilot trial to evaluate the effectiveness, feasibility, and acceptability of an AI-powered robotic dog intervention in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Participants will be randomly assigned to either the intervention group, receiving standard care plus daily interaction with the AIBO robotic dog during the inpatient isolation period, or the control group, receiving standard post-transplant care alone.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share