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

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Andet: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Positive and Negative Affect
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Koç University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KOCUNIVR

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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