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

19 maggio 2026 aggiornato da: Eysan Hanzade Umac, Koç University

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Standard care & Control Group Care
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.
Sperimentale: Intervention Group (AIBO Group):
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.
Altro: 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 × 305 mm)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Positive and Negative Affect
Lasso di tempo: Baseline (Day 1, before intervention initiation) and weekly assessments during the intervention period at Weeks 2, 3, and 4.
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
Lasso di tempo: Baseline (Day 1, before intervention initiation) and weekly assessments during the intervention period at Weeks 2, 3, and 4.
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
Lasso di tempo: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Koç University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

30 giugno 2028

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KOCUNIVR

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be shared publicly due to the small sample size and privacy considerations related to pediatric participants.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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