Enhancing Pain Management Among Patients Diagnosed With Stage III and Stage IV of Breast Cancer: The Power of Immersive and Non-Immersive Virtual Reality-Driven Interactive Guided Imagery

Официальное название

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)

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Immersive Virtual reality guided imagery
  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
• Устройство VR (VR-Control)
  non immersive /vr

Первичные конечные точки

• 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. [Срок оценки: 6 weeks]
• Cancer pain pre and post [Срок оценки: 6 weeks-8weeks]

Критерии участия

Критерии включения

• 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. Exclusion Criteria
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Иордания · 1 центр

• Middle east university — Amman

Идентификаторы

NCT: NCT07497451 · MOH/REC/2024/138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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