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临床试验/NCT07745946
NCT07745946已完成不适用

The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety During Chemotherapy Treatment in Breast Cancer Patients: A Randomized Controlled Trial

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
Change in Anxiety Level

研究概览

简要总结

This study was conducted to determine the effect of virtual reality glasses use and breathing exercise application on anxiety levels in breast cancer patients undergoing chemotherapy treatment.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The results were evaluated by a statistician independent of the study, without knowledge of the group assignments.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Virtual Reality Glasses Group

Experimental

Use of virtual reality glasses during chemotherapy sessions

干预措施: Virtual Reality Glasses (Behavioral)

Control (Standard Care)

No Intervention

Breathing Exercise Group

Experimental

Breathing exercise applied during chemotherapy sessions

干预措施: Breathing exercise (Behavioral)

结局指标

主要结局

Change in Anxiety Level

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Ankara Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hülya Elmalı Şimşek

Asst. Prof.

Ankara Medipol University

研究点 (1)

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