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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye)
- Ankara Medipol University
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
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]
Otros nombres:
|
|
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]
|
|
Sin intervención: Control (Standard Care)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Anxiety Level
Periodo de tiempo: 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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Neoplasias por sitio
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias
- Desórdenes de ansiedad
- Neoplasias de mama
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Técnicas de movimiento del ejercicio
- Modalidades de fisioterapia
- Ejercicios de respiración
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2025-03/18
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .