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

March 24, 2026 updated by: Bushra kh Alhusamiah, Middle East University

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Amman, Jordan, 11831
        • Middle East University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immersive Virtual Reality-Assisted Guided Imagery
Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive immersive 360-degree VR-guided imagery for cancer pain management.
Device: 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

Other Names:
  • Standard care
  • non immersive VR
Experimental: Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D V
Non immersive
Device: VR (VR-Control)
non immersive /vr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
6 weeks
Cancer pain pre and post
Time Frame: 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
6 weeks-8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Middle East University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOH/REC/2024/138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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