The Effect of Using Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy Among Adult Cancer Patients Undergoing Chemotherapy in the West Bank
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in pain intensity during chemotherapy
研究概览
简要总结
The main purpose of this study is to examine the effect of using AVR on pain, stress, anxiety, and SE among adult cancer patients undergoing chemotherapy in the West Bank hospitals in Palestine. The main questions it aims to answer are:
- What is the effect of AVR therapy on pain levels score compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the stress levels compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the anxiety compared with routine care during chemotherapy session among cancer patients?
- What is the effect of AVR therapy on the general SE compared with routine care during chemotherapy session among cancer patients?
The participants divided into two groups, the intervention group, which receives AVR, and the control group, which receives standard treatment. The study used a pretest and posttest design to assess the effect of AVR on the study variables (pain, stress, anxiety and self-efficacy).
详细描述
This study was designed as a randomized control trial (RCT), including both pretest and posttest assessments.
Participants were randomly assigned to either the intervention group, which received AR, or the control group, which received standard treatment. Random assignment was conducted using a computer-generated list of patients scheduled for chemotherapy, with patients alternately assigned to the intervention and control group (e.g., patient number 1 to the intervention group, number 2 to the control group). This process was managed by a nurse who was blinded to the study protocol. Due to the nature of the study, the researchers were not blinded.
The study was conducted in three large hospitals in northern Palestine that specialized in oncology care, particularly within their chemotherapy units.
The sample consisted of cancer patients undergoing chemotherapy in the aforementioned hospitals. Pretests, interventions, and posts were conducted .Inclusion criteria were cancer patients (over 18 years old) who required chemotherapy and could provide informed consent in Arabic. Exclusion criteria included a history of VR motion sickness, physical or cognitive limitations preventing VR headset use, visual, auditory, or vestibular impairments, uncontrolled severe medical conditions (e.g., vomiting, nausea, respiratory depression), pediatric patients, cognitive impairments, and any mental or psychological disorders.
Questionnaires were used to gather the data. It consists of three sections:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-60 years undergoing chemotherapy for breast or colon cancer.
- •Stage I or II cancer, as defined by the study protocol.
- •Manageable levels of pain, anxiety, and stress, appropriate for participation in the intervention.
排除标准
- •Age over 60 years.
- •Cancer types other than breast or colon cancer.
- •Severe pain, anxiety, or stress that could interfere with participation or require intensive care beyond the study scope.
研究组 & 干预措施
Control Group (Standard Chemotherapy Care)
the control group participated in routine sessions without AVR. Patients were admitted to the daycare unit, where a cannula was applied. The nurse then followed the doctor's order for the type of medication that would be given to the patient. Subsequently, the patients filled out the questionnaire at the posttest.
AVR Group
Patients receive standard chemotherapy care plus Augmented Virtual Reality (AVR) distraction sessions during chemotherapy infusion.
干预措施: AVR Group (Chemotherapy + AVR) (Behavioral)
结局指标
主要结局
Change in pain intensity during chemotherapy
时间窗: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. The outcome will be the change in NPRS score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
Change in pain intensity during chemotherapy
时间窗: Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. The outcome will be the change in NPRS score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.
次要结局
- Change in self-efficacy during chemotherapy(Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).)
- Change in self-efficacy during chemotherapy(Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).)
- Change in perceived stress during chemotherapy(Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).)
- Change in anxiety symptoms during chemotherapy(Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).)
研究者
Farid Salih Abu lie
academic lecturer
Arab American University (Palestine)