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Social Robot Interaction on Fear and Pain Levels in Children

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34010
        • Koç University

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

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Eksperimentel: social robot
Andet: Social Robot
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.
Eksperimentel: digital game
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
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
Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
Children Fear Scale
Tidsramme: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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.
Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.

Samarbejdspartnere og efterforskere

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

Sponsor

Trakya University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • REFERENCES Altman, I., & Taylor, D. A. (1973). Social penetration: The development of interpersonal relationships. Holt, Rinehart and Winston. Ball, J. W., Bindler, R. C., Cowen, K. J., & Shaw, N. M. (2017). Child health nursing: Partnering with children and families (3rd ed.). Pearson. Beran, T. N., Ramirez-Serrano, A., Vanderkooi, O. G., & Kuhn, S. (2013). Reducing children's pain and distress towards flu vaccinations: A novel and effective application of humanoid robotics. Vaccine, 31(25), 2772-2777. https://doi.org/10.1016/j.vaccine.2013.03.056 Birnie, K. A., Noel, M., Chambers, C. T., Uman, L. S., & Parker, J. A. (2018). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews, 10(10), CD005179. https://doi.org/10.1002/14651858.CD005179.pub4 Blount, R. L., Zempsky, W. T., Jaaniste, T., Evans, S., Cohen, L. L., Devine, K. A., & Inadomi, H. (2009). Management of pediatric pain and distress due to medical procedures. In M. C. Roberts & R. G. Steele (Eds.), Handbook of pediatric psychology (4th ed., pp. 171-188). Guilford Press. Boutron, I., Altman, D. G., Moher, D., Schulz, K. F., & Ravaud, P. (2017). CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Annals of Internal Medicine, 167(1), 40-47. https://doi.org/10.7326/M17-0046 Campbell, K. A. (2022). The neurobiology of childhood trauma, from early physical pain onwards: As relevant as ever in today's fractured world. European Journal of Psychotraumatology, 13(2), Article 2131969. https://doi.org/10.1080/20008066.2022.2131969 Dawe, J., Sutherland, C., Barco, A., & Broadbent, E. (2019). Can social robots help children in healthcare contexts? A scoping review. BMJ Paediatrics Open, 3(1), Article e000371. https://doi.org/10.1136/bmjpo-2018-000371 Eijlers, R., Utens, E. M. W. J., Staals, L. M., de Nijs, P. F. A., Berghmans, J. M., Wijne

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 (Faktiske)

21. december 2025

Primær færdiggørelse (Faktiske)

21. december 2025

Studieafslutning (Faktiske)

30. april 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1 (Mobile Health and Wellness Program)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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