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

19. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

28

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Experimental: 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.
Sonstiges: 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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Positive and Negative Affect
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Koç University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KOCUNIVR

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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