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.
