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

NCT07497451 | Not Yet Recruiting DMC

• 1 other identifier: MOH/REC/2024/138
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Pain; Virtual Reality Immersion

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  6 weeks-8weeks

Study Arms (2)

Immersive Virtual Reality-Assisted Guided Imagery

EXPERIMENTAL

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

Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D V

EXPERIMENTAL

Non immersive

Device: VR (VR-Control)

Interventions

Immersive Virtual reality guided imagery DEVICE

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

Also known as: non immersive VR, Standard care

Immersive Virtual Reality-Assisted Guided Imagery

VR (VR-Control) DEVICE

non immersive /vr

Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Middle East University: lead

Study Sites (1)

Middle east university

Amman, 11831, Jordan

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bushra Alhusamiah, Ph.D

CONTACT

+962791259774; b.husamia@meu.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: tudy Interventions This study will include two interventional groups and one control (comparison) group, with each interventional group receiving a specific protocol tailored to the type of virtual reality (VR) technology. All participants, including those in the control group, will continue to receive standard cancer pain management care as usual throughout the study period. A. Immersive Virtual Reality-Assisted Guided Imagery Group Participants in this group will be fully engaged in an immersive 360-degree VR environment, designed to direct attention away from the real world toward the virtual setting. This immersive experience is expected to enhance cognitive engagement and facilitate pain distraction. The researcher will provide participants with instructions regarding the use of immersive VR devices and an overview of the three VR modules. Participants will be instructed to raise their hand if they experience severe nausea, dizziness, or vomiting, in which case the session wil

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

JO (1)