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Distraction Methods for Reducing Pain and Fear During Blood Draw in Children (PED-DISTRACT)

14. august 2026 oppdatert av: Gülsev Kutman

Effects of Pinwheel Blowing, 3D Hologram Viewing, and Gum Chewing on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial

Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated.

A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention.

Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is a four-arm, parallel-group randomized controlled trial involving children aged 5-10 years undergoing blood draw in a pediatric phlebotomy unit. The study aims to compare three nonpharmacological methods involving different mechanisms: active distraction through pinwheel blowing, passive visual distraction through 3D hologram viewing, and rhythmic oral and gustatory stimulation through flavored gum chewing.

Eligible children will be assigned to the study groups in a 1:1:1:1 ratio using block randomization stratified by sex (female or male) and age group (5-7 or 8-10 years). A block size of four will be used within each stratum.

In the pinwheel blowing group, children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. In the 3D hologram viewing group, children will watch an age-appropriate holographic video featuring colorful flying butterflies, beginning one minute before the blood draw and continuing until the procedure is completed. In the gum chewing group, children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue throughout the procedure. Children in the control group will receive the routine blood draw procedure without any additional pharmacological or nonpharmacological pain-relieving intervention. The accompanying parent will remain with the child throughout the procedure.

All blood draws will be performed by the same nurse, who has at least five years of pediatric phlebotomy experience, using a standardized procedure. Pain experienced during the blood draw will be assessed using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10. Fear will be assessed using the Children's Fear Scale, which ranges from 0 to 4. Immediately after the procedure, pain and fear will be rated independently by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will be evaluated using a single-item numerical rating scale ranging from 1 to 10.

Because of the visible nature of the interventions, the children, parents, researcher delivering the interventions, phlebotomy nurse, and observer nurse cannot be blinded to group allocation.

Studietype

Intervensjonell

Registrering (Antatt)

164

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
      • Tekirdağ, Tyrkia (Türkiye)
        • Rekruttering
        • Tekirdağ City Hospital

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 5 to 10 years
  • Scheduled to undergo a blood draw
  • No analgesic medication use within 6 hours before the procedure
  • No visual, hearing, or speech impairment
  • No neurological disorder
  • No oral or jaw condition that may prevent gum chewing
  • No chronic illness requiring frequent invasive procedures
  • Written informed consent provided by the parent or legal guardian
  • Verbal assent provided by the children

Exclusion Criteria:

  • Previous history of syncope during blood draw procedures
  • Blood draw not completed on the first attempt
  • Development of syncope during the procedure
  • Inability or unwillingness to complete the assigned intervention
  • Withdrawal of consent or assent by the parent or child at any stage of the 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
Eksperimentell: 3D Hologram Viewing Group
Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The intervention will begin one minute before the blood draw and continue until the procedure is completed.
Atferdsmessig: 3D Hologram Viewing
Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed.
Eksperimentell: Pinwheel Blowing Group
Children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed.
Atferdsmessig: Pinwheel Blowing
Children blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary.
Eksperimentell: Gum Chewing Group
Children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue until the procedure is completed.
Atferdsmessig: Gum Chewing
Children will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed.
Ingen inngripen: Control Group
Children will receive the routine blood draw procedure used in the pediatric phlebotomy unit. No additional pharmacological or nonpharmacological pain-relieving intervention will be provided. The accompanying parent will remain with the child and may talk to and maintain eye contact with the child during the procedure.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsramme: Immediately after the blood draw, within approximately 5 minutes
Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Immediately after the blood draw, within approximately 5 minutes
Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale
Tidsramme: Immediately after the blood draw, within approximately 5 minutes
Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.
Immediately after the blood draw, within approximately 5 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parent-Reported Satisfaction With the Blood Draw Procedure
Tidsramme: Immediately after the blood draw, within approximately 5 minutes
Parental satisfaction with the care provided during the blood draw procedure will be assessed using a single-item numerical rating scale ranging from 1 to 10, where 1 indicates the lowest level of satisfaction and 10 indicates the highest level of satisfaction. Higher scores indicate greater parental satisfaction.
Immediately after the blood draw, within approximately 5 minutes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gülsev Kutman

Samarbeidspartnere

Tekirdağ City Hospital

Etterforskere

  • Hovedetterforsker: Gülsev Kutman, Tekirdağ City Hospital

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)

15. juni 2026

Primær fullføring (Antatt)

15. september 2026

Studiet fullført (Antatt)

15. september 2026

Datoer for studieregistrering

Først innsendt

8. august 2026

Først innsendt som oppfylte QC-kriteriene

14. august 2026

Først lagt ut (Faktiske)

18. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KUTMAN-PED-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared because the informed consent process and ethics committee approval did not include the sharing of participant-level data with other researchers. As the study involves children, participant privacy and confidentiality will be strictly protected. Only aggregate study findings will be reported in scientific publications.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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