Effect of Virtual Reality on Pain and Anxiety During Chemotherapy Session in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of pain intensity
研究概览
简要总结
This study will be conducted to determine the effect of virtual reality exercise on pain and anxiety in breast cancer patients during chemotherapy treatment
详细描述
Many breast cancer survivors experience physical and psychological symptoms (such as pain, fatigue, depression, anxiety, and lymphedema); functional deficits (such as reduced shoulder range of motion and cognitive impairment); emotional problems (such as fatigue, pain, anxiety, and depression); and other complications such as bleeding, effusion, and flap necrosis. Side effects from breast cancer or treatment can have a significant impact on the quality of life (QoL) of breast cancer survivors.
Anxiety is present in about 10% of people during chemotherapy, while one-third of people with depression also show clinically significant anxiety states.
Pain occurs in 90% of patients treated with chemotherapy. Pain includes that produced by the neurotoxic action of antiblastic drugs, mechanical pressure of the tumor mass, metastases and pain in the phantom limb.
Over the last two decades, virtual reality (VR), has shown efficacy as a distraction tool to alleviate pain and distress during medical procedures. The need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of virtual reality on pain and anxiety in cancer patient during chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with breast cancer.
- •Patients who suffered from pain.
- •Patient who suffered from anxiety.
- •Patients who received chemo since 1cycle (session).
- •Patients who received the same type of chemotherapy.
- •Patients who are not suffer from anxiety disorders before chemotherapy.
- •Patient who received chemotherapy for the first time in their treatment.
排除标准
- •The potential participants will be excluded if they have one of the following criteria:
- •injuries to the face or head
- •Hand Injuries.
- •Cognitive impairment
- •A history of severe motion sickness
- •Mental health problems.
- •Visual and auditory problems.
- •Radiotherapy
- •A history of skull structure or cervical spine abnormalities that may complicate the use of VR devices.
- •A history of epilepsy, seizures, vertigo.
结局指标
主要结局
Assessment of pain intensity
时间窗: 6 weeks
Numerical rating scale (NRS) will be used to assess pain intensity. Pain levels will assess after the start of chemo infusion and immediately after intervention of VR for each session. The type of pain measured refers to any painful symptomatology that a cancer patient undergoing chemotherapy may experience. NRS score: "no pain = 0," "mild pain = 1-4," "moderate pain = 5-6," and "severe pain = 7-10."
Assessment of anxiety
时间窗: 6 weeks
Hamilton anxiety scale (HAM-A) will be used to assess anxiety level. The HAM-A entails 14 items, each categorized by a series of symptoms, and measures mental agitation and psychological distress, as well as anxiety-related physical complaints. The responses on the scale were measured on a 5-point Likert scale: 0 (symptoms not present), 1 (mild symptoms), 2 (moderate symptoms), 3 (severe symptoms) and 4 (very severe symptoms). The total score was calculated by summation of the 14 items. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
次要结局
未报告次要终点
研究者
Hanaa Hassanin Shehata Hassan
Principal investigator
Cairo University