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- Essai clinique NCT07604389
AR Health Education Video for Postoperative Breast Cancer Patients (AR-BCS)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taichung City
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Taichung, Taichung City, Taïwan, 435
- Recrutement
- Tungs' Taichung MetroHarbor Hospital
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Contact:
- Hsin-Hua Chen, RN, MSN
- Numéro de téléphone: +886919090022
- E-mail: yugagn@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: Routine Health Education Group
Routine perioperative health education provided according to standard clinical nursing care procedures.
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Routine perioperative health education provided according to standard clinical nursing care procedures.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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State Anxiety
Délai: Baseline, postoperative day 1, and postoperative day 2
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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.
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Baseline, postoperative day 1, and postoperative day 2
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depression
Délai: Baseline, postoperative day 1, and postoperative day 2
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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.
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Baseline, postoperative day 1, and postoperative day 2
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Physiological Indicators
Délai: Baseline, postoperative day 1, and postoperative day 2
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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.
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Baseline, postoperative day 1, and postoperative day 2
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TTMHH-R1140011 (Autre identifiant: Research Department, Tungs' Taichung MetroHarbor Hospital)
- 113090 (Autre identifiant: Institutional Review Board of Tungs' Taichung MetroHarbor Hospital)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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