Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care
详细描述
This study is a randomized controlled trial with a parallel-group design conducted to evaluate the effect of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing chemotherapy at the National Hospital for Oncology and Hematology in Najaf Governorate, Iraq.
Eligible participants will be randomly allocated into two groups in a 1:1 ratio using block randomization with a fixed block size of four. The experimental group will receive virtual reality-guided imagery in addition to routine hospital care, while the control group will receive routine care only.
The intervention will be delivered during chemotherapy sessions over the study period. The content of the virtual reality-guided imagery will be designed to promote relaxation and psychological comfort, aiming to reduce symptom burden during chemotherapy administration.
Primary and secondary outcomes will be assessed using validated instruments. Pain intensity will be measured using the Numerical Rating Scale (NRS). Anxiety levels will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, and fatigue will be measured using the Brief Fatigue Inventory (BFI). Assessments will be conducted at baseline and after the intervention period.
Data will be analyzed by comparing changes in outcomes between the intervention and control groups to determine the effectiveness of virtual reality-guided imagery in improving symptom management among cancer patients undergoing chemotherapy.
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 study is single-blinded. Due to the nature of the intervention, participants will be aware of whether they receive virtual reality-guided imagery or routine care. However, the outcome assessor responsible for collecting and evaluating study data will be blinded to group allocation to minimize assessment bias. This approach is used to ensure objectivity in outcome measurement and improve the internal validity of the study.
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
- •Female patients aged 18 years or older.
- •Histologically confirmed breast cancer.
- •Stage I, II, or III breast cancer.
- •Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).
- •Able to read, write, and communicate.
- •Able and willing to use a virtual reality headset.
- •Able to provide written informed consent.
排除标准
- •Visual or hearing impairment that prevents the use of virtual reality.
- •Serious neurological or psychiatric disorders.
- •Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.
- •Previous experience with virtual reality-guided imagery.
- •Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.
结局指标
主要结局
Pain intensity
时间窗: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 scale where higher scores indicate greater pain severity. The assessment will be conducted at baseline and after the intervention period to evaluate changes in pain levels between the intervention and control groups.
次要结局
- Anxiety level(Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3))
- Fatigue level(Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3))
研究者
Thoalfokar Mohammed Al-Obaidi
PhD Candidate
University of Baghdad