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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eysan SavaÅŸ, PhD | Contact | +90 5068418841 | eysansavas@gmail.com | |
| Remziye Semerci, PhD | Contact | +90 535 0112821 | remziyesemerci@gmail.com |
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Individual participant data (IPD) will not be shared publicly due to the small sample size and privacy considerations related to pediatric participants.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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.
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No masking will be applied in this study due to the nature of the intervention.
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