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AR Health Education Video for Postoperative Breast Cancer Patients (AR-BCS)

17. mai 2026 oppdatert av: Tungs' Taichung Metroharbour Hospital

Effects of AR Health Education Video Intervention on Anxiety and Depression in Postoperative Breast Cancer Patients

Breast cancer surgery patients may experience anxiety and depression before and after surgery. Health education can help patients understand the surgical process and postoperative care, but traditional education may not always be easy to understand.

This study evaluates whether augmented reality (AR) health education videos can help reduce anxiety and depression in postoperative breast cancer patients. Participants are randomly assigned to one of two groups. One group receives routine health education plus AR health education videos, and the other group receives routine health education only.

The study compares changes in anxiety, depression, and selected physiological indicators between the two groups before and after surgery.

Studieoversikt

Detaljert beskrivelse

This is a randomized controlled study. Eligible breast cancer surgery patients are randomly assigned to an AR health education group or a routine health education group.

Participants in the AR health education group receive routine perioperative health education plus AR health education videos. Participants in the routine health education group receive routine perioperative health education only.

An outcome assessor who is blinded to group allocation collects questionnaire data before surgery, on postoperative day 1, and on postoperative day 2. Anxiety is measured using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), and depression is measured using the Beck Depression Inventory-II (BDI-II). Physiological indicators, including heart rate, respiratory rate, blood pressure, and oxygen saturation, are also collected.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Taichung City
      • Taichung, Taichung City, Taiwan, 435
        • Rekruttering
        • Tungs' Taichung MetroHarbor Hospital
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Female patients aged 18 years or older with breast cancer.
  • Breast cancer confirmed by pathological examination.
  • Conscious and able to communicate in Mandarin or Taiwanese.
  • No visual or hearing impairment.
  • Willing to participate in this study and provide informed consent.

Exclusion Criteria:

  • Patients with brain metastasis, dementia, or cognitive impairment.
  • Patients currently taking antidepressants, anxiolytics, or other psychiatric medications.
  • Patients diagnosed with psychiatric disorders.
  • Patients with a history of hypertension.

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AR Health Education Group
Participants receive routine perioperative health education in addition to augmented reality (AR) health education videos related to breast cancer surgery and postoperative care.
An augmented reality (AR)-based health education video designed to provide perioperative education, postoperative recovery guidance, daily activity adjustment, and self-care information for breast cancer surgery patients.
Aktiv komparator: Routine Health Education Group
Routine perioperative health education provided according to standard clinical nursing care procedures.
Routine perioperative health education provided according to standard clinical nursing care procedures.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
State Anxiety
Tidsramme: Baseline, postoperative day 1, and postoperative day 2
State anxiety is measured using the Chinese version of the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S). The STAI-S includes 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. Scores of 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and 60 to 80 indicate severe anxiety.
Baseline, postoperative day 1, and postoperative day 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depression
Tidsramme: Baseline, postoperative day 1, and postoperative day 2
Depression is measured using the Chinese version of the Beck Depression Inventory-II (BDI-II). The BDI-II includes 21 items rated from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms. Scores of 0 to 16 indicate normal range, 17 to 22 indicate mild depression, 23 to 30 indicate moderate depression, and 31 to 63 indicate severe depression.
Baseline, postoperative day 1, and postoperative day 2
Physiological Indicators
Tidsramme: Baseline, postoperative day 1, and postoperative day 2
Physiological indicators include heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, and peripheral oxygen saturation. These indicators are collected to assess physiological responses related to anxiety during the perioperative period.
Baseline, postoperative day 1, and postoperative day 2

Samarbeidspartnere og etterforskere

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

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)

17. juni 2025

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • TTMHH-R1140011 (Annen identifikator: Research Department, Tungs' Taichung MetroHarbor Hospital)
  • 113090 (Annen identifikator: Institutional Review Board of Tungs' Taichung MetroHarbor Hospital)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Individual participant data (IPD) sharing has not yet been determined. Data may be shared upon reasonable request and after approval by the corresponding author and institutional review board.

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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