Cancer PainNCT07497451
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
A study testing Immersive Virtual reality guided imagery in people with Cancer Pain and Virtual Reality Immersion, run by Middle East University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Virtual Reality Immersion
- What is being tested?
- Immersive Virtual reality guided imagery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJordan
- Study dates
- 20 Mar 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Middle east university
Amman, 11831
Bushra Alhusamiah, 0791259774 ext. 0791259774, b.husamia@meu.edu.jo
About this study
Official title: 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.
Read more
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
Read the 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.
- 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.
- 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.
- Conditions
- Cancer Pain, Virtual Reality Immersion
- Being tested
- Immersive Virtual reality guided imagery, VR (VR-Control)
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual reality guided imageryDevice
Also called non immersive VR, Standard care
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
VR (VR-Control)Device
non immersive /vr
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Immersive Virtual reality guided imagery |
| Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D V | Experimental | Non immersive Receives: Device: VR (VR-Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Cancer pain pre and post
- 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
Measured: 6 weeks-8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra kh Alhusamiah, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497451
- Sponsor's protocol ID
- MOH/REC/2024/138
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07497451
- Acronym / sponsor ID
- MOH/REC/2024/138
- Conditions
- Cancer Pain, Virtual Reality Immersion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality-Assisted Guided Imagery | Experimental | Device: Immersive Virtual reality guided imageryImmersive 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 V | Experimental | Device: VR (VR-Control)Non immersive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual reality guided imageryAlso: non immersive VR, Standard careImmersive 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 | Device | Immersive Virtual Reality-Assisted Guided Imagery |
| VR (VR-Control)non immersive /vr | Device | Non-Immersive Virtual Reality-Assisted Guided Imagery - Participants will receive non-immersive 3D V |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual reality guided imagery in people with Cancer Pain and Virtual Reality Immersion, run by Middle East University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bushra Alhusamiah, Ph.D (+962791259774, b.husamia@meu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.