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
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 To evaluate the effectiveness of immersive VR-assisted guided imagery in reducing cancer-related pain among patients with advanced breast cancer. To evaluate the effectiveness of non-immersive VR-assisted guided imagery in reducing cancer-related pain among patients with advanced breast cancer. To compare the outcomes between immersive VR, non-immersive VR, and standard care (control) groups regarding pain intensity and simulator sickness symptoms. To assess the feasibility, acceptability, and safety of immersive and non-immersive VR interventions in the oncology clinical setting. Theoretical Framework This study will be guided by the Gate Control Theory of Pain, which posits that psychological and sensory factors can modulate pain perception by "closing the gate" to nociceptive signals in the spinal cord. VR-assisted guided imagery interventions are expected to provide a cognitive and sensory distraction, thereby inhibiting pain transmission and reducing subjective pain perception. Additionally, the study will incorporate principles from Cognitive Behavioral Theory, as guided imagery promotes active engagement of attention and cognitive reframing of pain experiences. Study Design This research will employ a quantitative, quasi-experimental pretest-posttest design with three study groups. Participants will be assigned to one of the following groups: Immersive VR-assisted guided imagery group Non-immersive VR-assisted guided imagery group Control group (standard care) The quasi-experimental design is selected because it allows the researcher to assign participants based on eligibility criteria while ensuring safety and feasibility within a clinical oncology setting. Pain and simulator sickness outcomes will be measured at two time points: baseline (pre-intervention) and immediately after the intervention (post-intervention). This pretest-posttest design will enable the evaluation of short-term intervention effects and comparison between groups. Study Setting The study will be conducted at the largest public hospital in Jordan, located in East Amman. This hospital is a leading healthcare institution serving the Jordanian population, with a capacity of approximately 1,000 beds and providing services to over 7,000 patients daily. The hospital has a dedicated oncology department, established in collaboration with the largest specialized oncology center in Jordan. The department includes six weekly clinics and a pain management and palliative care clinic, which provides care to more than 250 patients per month. Participants will be recruited primarily from the cancer pain management clinic to ensure access to patients with advanced breast cancer experiencing pain. Population and Sampling Target Population Adult patients (≥18 years old) with advanced-stage breast cancer experiencing cancer-related pain who are receiving care in oncology clinics in Jordan. Accessible Population Patients receiving treatment in the selected oncology department at the public hospital during the study period, who meet eligibility criteria. Sampling Technique Purposive, non-probability sampling will be used to recruit participants who meet predefined inclusion and exclusion criteria. This approach will ensure selection of participants who can safely and effectively participate in VR-assisted guided imagery interventions. Sample Size Calculation The minimum sample size will be determined using G\*Power version 3.1.10, based on repeated-measures ANOVA with within-between interactions. Assuming a medium effect size (f = 0.25), α = 0.05, and power = 0.80, the minimum required sample size is 62 participants. To account for potential dropout (\~10%) and improve statistical power, the study will recruit 90 participants, equally allocated to the three groups (n=30 per group). Study Interventions A. Immersive VR-assisted Guided Imagery Participants will experience a fully immersive 360-degree VR environment via a head-mounted display (HMD) and noise-canceling headphones. The session will last approximately 45 minutes and include three interactive guided imagery modules: Natural landscapes and relaxation environments Underwater exploration with interactive marine life 360-degree virtual roller coaster in natural environments Participants will be instructed to report any severe nausea, dizziness, or discomfort, with procedures in place for immediate discontinuation if necessary. B. Non-immersive VR-assisted Guided Imagery Participants will interact with 3D VR content on a laptop with headphones and input devices (mouse/keyboard). Three modules will be provided similar to immersive VR, designed to promote relaxation, engagement, and distraction. The total session duration will be 45 minutes. C. Control Group (Standard Care) Participants will continue to receive standard cancer pain management guided by the WHO analgesic ladder, including non-opioid analgesics, weak opioids, and strong opioids according to pain severity. Pain assessments will be conducted at baseline and after a 45-minute waiting period (equivalent to intervention duration). Data on demographics and clinical characteristics Age, marital status, educational level, employment status Cancer stage, treatment history, medication usage, and comorbidities Data Collection Procedure Pre-Phase (Recruitment) IRB approval will be obtained from the university and hospital. Eligible participants will be identified through medical records and approached during scheduled clinic visits. Informed consent and study information will be provided. Intervention Phase Participants in VR groups will complete baseline assessments and receive VR sessions. Participants will be monitored for adverse events during the session. Post-Intervention Phase Pain and simulator sickness outcomes will be reassessed immediately after intervention sessions. Control group participants will undergo outcome assessment after equivalent waiting periods. Ethical Considerations Approval will be obtained from the Institutional Review Board (IRB). Written informed consent will be obtained. Confidentiality will be maintained, and participants may withdraw at any time. Adverse events will be monitored and managed according to safety protocols. Statistical Analysis Data will be analyzed using repeated-measures ANOVA to assess within- and between-group differences in pain intensity and simulator sickness scores. Descriptive statistics will summarize demographic and clinical characteristics. Effect sizes and confidence intervals will be reported. Expected Outcomes Immersive VR-assisted guided imagery is hypothesized to significantly reduce pain intensity and improve patient engagement compared to non-immersive VR and standard care. Non-immersive VR is expected to produce moderate pain reduction. Both VR interventions are anticipated to be safe, feasible, and well-tolerated. Findings will inform the integration of VR-assisted interventions into oncology supportive care in Jordan and similar clinical settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
90
Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive immersive 360-degree VR-guided imagery for cancer pain management. Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D VR-guided imagery for cancer pain management using laptops and input devices
non immersive /vr
Middle east university
Amman, Jordan
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.
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.
Time frame: 6 weeks
Cancer pain pre and post
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
Time frame: 6 weeks-8weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.