Enhancing Pain Management Among Patients Diagnosed With Stage III and Stage IV of Breast Cancer: The Power of Non-Immersive Virtual Reality-Driven Interactive Guided Imagery: A Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cancer Related pain The numeric pain rating scale (NPRS) is a tool used to assess the intensity of pain experienced by adults. It is a unidimensional measure that allows individuals to quantify and communicate their pain levels.
研究概览
简要总结
Cancer-related pain is one of the most common and distressing symptoms experienced by patients with advanced cancer, particularly among women diagnosed with advanced breast cancer. Pain associated with cancer may arise from tumor progression, metastasis, or cancer treatments, and it often has a substantial negative impact on patients' physical functioning, emotional well-being, and overall quality of life. Although pharmacological pain management strategies remain the primary approach for managing cancer-related pain, many patients continue to report inadequate pain relief or experience undesirable side effects from medications. For this reason, healthcare providers and researchers are increasingly exploring complementary and non-pharmacological interventions that can be used alongside standard pain management strategies.
Current clinical practice for cancer pain management commonly follows the analgesic ladder recommended by the World Health Organization, which involves a stepwise approach using non-opioid analgesics, weak opioids, and strong opioids depending on the severity of the patient's pain. While this approach has significantly improved pain control in many patients, it does not completely eliminate pain in all cases, and additional supportive interventions are often required. In recent years, digital health technologies such as virtual reality (VR) have emerged as promising tools that may support pain management through distraction, relaxation, and cognitive engagement.
Virtual reality is an interactive computer-generated environment that can simulate real or imaginary settings and allow users to experience immersive or semi-immersive sensory stimulation. VR-based interventions have gained increasing attention in healthcare due to their potential to reduce pain perception by diverting attention away from painful stimuli and promoting psychological relaxation. In particular, VR-assisted guided imagery interventions have been proposed as a therapeutic approach that combines visual and auditory stimuli with relaxation techniques to enhance patients' cognitive engagement and emotional comfort.
VR technology can be delivered through different levels of immersion. Immersive VR typically uses a head-mounted display to create a fully interactive three-dimensional environment that surrounds the user and blocks out external stimuli, providing a highly engaging experience. In contrast, non-immersive VR systems present virtual environments through computer screens or similar devices, allowing users to remain aware of their physical surroundings while interacting with digital content. Although both approaches may contribute to pain reduction through distraction and relaxation mechanisms, limited evidence exists regarding the comparative effectiveness of immersive versus non-immersive VR interventions in the management of cancer-related pain.
Therefore, the purpose of this study is to evaluate the effectiveness of immersive and non-immersive virtual reality-assisted guided imagery interventions in reducing cancer-related pain among patients with advanced breast cancer in Jordan. The study aims to determine whether these interventions can provide additional benefits when used alongside standard cancer pain management practices.
This study will employ a quantitative quasi-experimental pre-post design with three study groups: an immersive virtual reality intervention group, a non-immersive virtual reality-assisted guided imagery group, and a control group receiving standard cancer pain management care. Participants in both intervention groups will engage in a 45-minute virtual reality session consisting of guided imagery experiences designed to promote relaxation and distraction from pain. The immersive VR group will use head-mounted display technology to experience a fully immersive 360-degree virtual environment, while the non-immersive VR group will view similar virtual content using a computer-based display system with audio support.
Pain intensity will be measured using the Arabic version of the Numerical Pain Rating Scale (NPRS) before the intervention and immediately after the intervention. In addition, symptoms associated with simulator sickness, such as nausea, dizziness, and visual discomfort, will be assessed using the Simulator Sickness Questionnaire (SSQ) to evaluate the safety and tolerability of the VR interventions.
The study will be conducted among adult patients diagnosed with advanced breast cancer who are receiving care at a cancer pain management clinic in a large public hospital in Jordan. Eligible participants will be adults aged 18 years or older who are experiencing cancer-related pain and are able to participate in the intervention sessions. A total of 90 participants will be recruited and allocated equally across the three study groups.
The findings of this study are expected to contribute to the growing body of evidence regarding the role of virtual reality technologies in suppo
详细描述
Background and Rationale
Pain is one of the most prevalent and distressing symptoms experienced by patients with advanced breast cancer, significantly impacting their physical, psychological, and social well-being. Despite advances in pharmacological pain management, including opioid and non-opioid analgesics, many patients continue to experience inadequate pain relief or experience undesirable side effects. Persistent pain is associated with increased anxiety, depression, sleep disturbances, and reduced quality of life. Therefore, there is a critical need to explore innovative, complementary non-pharmacological interventions that can enhance pain management strategies and improve patient outcomes.
Virtual reality (VR)-assisted interventions have emerged as a promising approach for managing pain and distress in clinical populations. VR provides a multisensory, interactive environment that can effectively distract patients from painful stimuli, induce relaxation, and enhance emotional coping. Immersive VR engages the user in a fully 360-degree interactive environment through head-mounted displays (HMD), while non-immersive VR allows interaction with 3D content on standard computer screens or laptops, preserving awareness of the real environment. Guided imagery is a cognitive-behavioral strategy that involves imagining relaxing, pleasant, or healing scenarios to reduce stress and perceived pain. When combined with VR technology, guided imagery can potentially enhance patients' ability to visualize and experience calming scenarios, thereby reducing pain intensity and emotional distress.
Although previous studies have demonstrated the efficacy of VR interventions in pain management, there is limited evidence comparing immersive versus non-immersive VR modalities for patients with advanced breast cancer. Moreover, data from Middle Eastern populations, including Jordan, are scarce. This study will address this gap by examining the short-term effectiveness of immersive and non-immersive VR-assisted guided imagery on cancer-related pain and related symptoms, including simulator sickness, among patients with advanced breast cancer in Jordan.
Study Objectives
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with advanced stage of breast cancer; based on pathological analysis (this Data from electronic medical record system).
- •Undergoing treatment in the selected Hospital
- •Age group >18 years of age (Adult)
- •Hospitalized patient at the selected study setting
- •Available at the time of data collection; the minimum expected admission time should be no less than 5 days, as the intervention is planned to last for 5 days.
- •Able to sign the consent form.
- •Willing to comply with study procedures and instructions.
- •has cancer pain.
排除标准
- •Individuals who are experiencing difficulties in their ability to hear or have a complete loss of hearing.
- •Individuals who suffer from extreme visual impairment or complete loss of vision.
- •Not willing to participate in the study.
- •Patient with Glasgow coma scale < 15
- •Individuals who experience persistent and uncontrollable feelings of nausea, vomiting, or dizziness, individuals with a background of motion sickness (Rational for exclusion: According to previous studies, the utilization of VR intervention may have adverse effects, including Dizziness, nausea, vomiting, and motion sickness (Simón-Vicente et al., 2022).As a result, in order to prevent the exacerbation of these symptoms among patients, they will not be included in the VR intervention)
- •Individuals with a history of seizures or epilepsy (Rational for exclusion: Individuals diagnosed with epilepsy have frequently been excluded from the participation in virtual reality (VR) research due to the concern that engaging with VR technology could potentially induce seizures in those who have photosensitive epilepsy (Gray et al., 2023)
- •A patient who has an injury at their eyes, face, or neck that hinders their ability to comfortably utilize virtual reality (VR) hardware or software or poses a safety risk when using the hardware (such as having open sores, wounds, or a skin rash on their face).
结局指标
主要结局
Cancer Related pain The numeric pain rating scale (NPRS) is a tool used to assess the intensity of pain experienced by adults. It is a unidimensional measure that allows individuals to quantify and communicate their pain levels.
时间窗: 6 weeks
Pain will be assessed before and after the intervention The numeric pain rating scale (NPRS) is a tool used to assess the intensity of pain experienced by adults. It is a unidimensional measure that allows individuals to quantify and communicate their pain levels. Furthermore, it is a widely used tool in the medical field for evaluating the intensity of pain experienced by individuals at a specific moment. It employs a scale ranging from 0 to 10, where a score of zero indicates the absence of pain and a score of 10 signifies the most excruciating pain one can imagine. This assessment method is frequently employed in various clinical settings. However, in this study the Arabic version of Numerical pain rating scale will be utilized, the researcher will ask the participants to evaluate their current pain level based on the scale.
Cancer pain pre and post
时间窗: 6 weeks-8weeks
B. Numerical pain rating scale (NPRS) The numeric pain rating scale (NPRS) is a tool used to assess the intensity of pain experienced by adults. It is a unidimensional measure that allows individuals to quantify and communicate their pain levels. Furthermore, it is a widely used tool in the medical field for evaluating the intensity of pain experienced by individuals at a specific moment. It employs a scale ranging from 0 to 10, where a score of zero indicates the absence of pain and a score of 10 signifies the most excruciating pain one can imagine. This assessment method is frequently employed in various clinical settings. However, in this study the Arabic version of Numerical pain rating scale will be utilized, the researcher will ask the participants to evaluate their current pain level based on the scale. In this scale, the intensity of pain is divided into four distinct categories, which are determined by the score provided by the patients; a score of 0 indicates the absence of
次要结局
未报告次要终点
研究者
Bushra kh Alhusamiah
Assistant Professor
Middle East University