- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07745946
The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety
The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety During Chemotherapy Treatment in Breast Cancer Patients: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Cancer remains one of the leading causes of morbidity worldwide, with anxiety recognized as one of the most frequently reported psychological symptoms among patients undergoing chemotherapy. In breast cancer patients specifically, anxiety has been shown to negatively affect quality of life, reduce treatment adherence, and intensify the perceived burden of other physical symptoms during chemotherapy sessions.
While pharmacological approaches remain part of standard symptom management, non-pharmacological interventions-such as distraction techniques, relaxation exercises, guided imagery, and music therapy-are increasingly used by nurses due to their low cost, safety, ease of implementation, and ability to actively engage patients in their own care. Among these, virtual reality (VR) technology has emerged as a promising distraction-based intervention, with prior studies reporting reductions in stress, anxiety, and treatment-related discomfort. Similarly, breathing exercises have demonstrated anxiolytic effects through their regulatory influence on the autonomic nervous system, with recent systematic reviews and meta-analyses confirming significant reductions in anxiety and depression among cancer patients.
Despite the individual evidence supporting each intervention, few studies have directly compared the effectiveness of virtual reality glasses and breathing exercises within the same patient population, and randomized controlled trials evaluating both interventions concurrently in breast cancer patients undergoing chemotherapy remain limited.
This study is designed as a randomized controlled trial to determine and compare the effects of virtual reality glasses and breathing exercise applications on anxiety levels in breast cancer patients receiving chemotherapy. Eligible participants will be randomly assigned to one of the study groups (virtual reality glasses, breathing exercise, or standard care/control), and anxiety will be assessed using a validated anxiety measurement instrument (State-Trait Anxiety Inventory, VAS) before and after the intervention during chemotherapy sessions.The findings of this study are expected to contribute to the evidence base for non-pharmacological anxiety management in oncology nursing practice and to help identify effective, low-cost interventions that can be integrated into routine chemotherapy care.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Ankara, Turquia (Türkiye)
- Ankara Medipol University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Diagnosed with breast cancer
- Aged 18 years or older
- Receiving treatment in the outpatient (day-case) chemotherapy unit
- Voluntarily agreeing to participate in the study
Exclusion Criteria:
- Having a respiratory-related disease
- Having visual or hearing impairment
- Having a communication problem
- Having a diagnosis of psychiatric disease
- Having a cancer diagnosis other than breast cancer
- Receiving ice-cap therapy to prevent/reduce hair loss or cryotherapy for hand-foot neuropathy during chemotherapy treatment
- Having vertigo or head-neck disorders
- Patients hospitalized for their first cycle of chemotherapy treatment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Breathing Exercise Group
Breathing exercise applied during chemotherapy sessions
|
Intervention 1: Breathing Exercise In this study, participants in the breathing exercise group will perform diaphragmatic (deep) breathing exercises during their chemotherapy sessions.
Diaphragmatic breathing promotes deeper, more controlled respiration through effective use of the diaphragm muscle, producing a balancing effect on the autonomic nervous system, while slow rhythmic breathing supports relaxation by increasing heart rate variability.
Participants will be guided by a nurse/researcher to perform the exercise for [10 minutes]
Outros nomes:
|
|
Experimental: Virtual Reality Glasses Group
Use of virtual reality glasses during chemotherapy sessions
|
Intervention 2: Virtual Reality Glasses Participants in the virtual reality group will wear VR glasses displaying calming, distraction-based visual and auditory content during their chemotherapy infusion.
This intervention aims to redirect attention away from the treatment process, thereby reducing perceived stress and anxiety.
The VR session will be applied for [10 minutes]
|
|
Sem intervenção: Control (Standard Care)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Anxiety Level
Prazo: Baseline (before intervention) and immediately after intervention during the chemotherapy session
|
Anxiety levels will be measured using a validated anxiety assessment tool ( State-Trait Anxiety Inventory [STAI], VAS, Vital Signs form before and after the intervention (virtual reality glasses, breathing exercise, or standard care) in each study group.
The change in anxiety scores between baseline and post-intervention will be compared across the three groups.
|
Baseline (before intervention) and immediately after intervention during the chemotherapy session
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Neoplasias por local
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias
- Transtornos de ansiedade
- Neoplasias da Mama
- Terapêutica
- Terapias mente-corpo
- Terapias complementares
- Técnicas de movimento do exercício
- Modalidades de fisioterapia
- Exercícios de respiração
Outros números de identificação do estudo
- 2025-03/18
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .