Social Robot Interaction on Fear and Pain Levels in Children
7. juni 2026 oppdatert av: Remziye Semerci, Trakya University
The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
- Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
- Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
- Be randomly assigned to one of three groups: social robot, digital game, or standard care.
- Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
- Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
- Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34010
- Koc University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Children aged 4-12 years
- Clinical indication for venous blood sampling
- Ability to communicate in Turkish
- No cognitive disabilities
- No sensory disabilities
- Parent or legal guardian provides informed consent
- Child provides verbal assent
Exclusion Criteria:
- Requirement for emergency medical intervention
- Use of analgesic medication within 6 hours prior to the procedure
- Diagnosis of developmental delay
- Previous participation in a social robot-based intervention or study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Kontrollgruppe
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Eksperimentell: social robot
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Children interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure.
The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain.
|
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Eksperimentell: digital game
|
Children received a digital game-based distraction intervention using the Bubble Rainbow application.
Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling.
During the procedure, children continued playing the game on a tablet device while receiving support from their parents.
The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Wong-Baker Faces Pain Rating Scale
Tidsramme: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale.
The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity
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Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Children Fear Scale
Tidsramme: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years.
The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.
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Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.
- Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. desember 2025
Primær fullføring (Faktiske)
21. desember 2025
Studiet fullført (Faktiske)
30. april 2026
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1 (Mobile Health and Wellness Program)
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