Virtual RealityVRGI-Chemo TriNCT07677436
Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy
A study testing Virtual Reality-Guided Imagery in people with Virtual Reality and Guided Imagery, run by Thoalfokar Mohammed Al-Obaidi at 1 site in Iraq.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Virtual Reality, Guided Imagery, Breast Cancer
- What is being tested?
- Virtual Reality-Guided Imagery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2026to Mar 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Histologically confirmed breast cancer.
- Stage I, II, or III breast cancer.
- Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).
- Able to read, write, and communicate.
- Able and willing to use a virtual reality headset.
- Able to provide written informed consent.
Who cannot join
- Visual or hearing impairment that prevents the use of virtual reality.
- Serious neurological or psychiatric disorders.
- Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.
- Previous experience with virtual reality-guided imagery.
- Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
thulfiqar mohammed abdalhussien, PhD candidate contact
Iraq1 site
National Hospital for Oncology and Hematology in Najaf Governorate
Najaf, Najaf Governorate
thoalfokar mohammed abdalhussien, PhD candidate, 07831476489, thulfiqar.abd2402p@conursing.uobaghdad.edu.iq
Thoalfokar Mohammed Al-Obaidi, PhD candidate
About this study
Official title: Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care
Read the detailed description
This study is a randomized controlled trial with a parallel-group design conducted to evaluate the effect of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing chemotherapy at the National Hospital for Oncology and Hematology in Najaf Governorate, Iraq.
Eligible participants will be randomly allocated into two groups in a 1:1 ratio using block randomization with a fixed block size of four. The experimental group will receive virtual reality-guided imagery in addition to routine hospital care, while the control group will receive routine care only.
The intervention will be delivered during chemotherapy sessions over the study period. The content of the virtual reality-guided imagery will be designed to promote relaxation and psychological comfort, aiming to reduce symptom burden during chemotherapy administration.
Primary and secondary outcomes will be assessed using validated instruments. Pain intensity will be measured using the Numerical Rating Scale (NRS). Anxiety levels will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, and fatigue will be measured using the Brief Fatigue Inventory (BFI). Assessments will be conducted at baseline and after the intervention period.
Data will be analyzed by comparing changes in outcomes between the intervention and control groups to determine the effectiveness of virtual reality-guided imagery in improving symptom management among cancer patients undergoing chemotherapy.
- Conditions
- Virtual Reality, Guided Imagery, Breast Cancer, Chemotherapy, Pain, Anxiety
- Being tested
- Virtual Reality-Guided Imagery
- Keywords
- Virtual Reality, Guided Imagery , Breast Cancer, Chemotherapy , Pain, Anxiety , Fatigue
- Medical subject headings
- Breast Neoplasms, Pain, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Guided ImageryDevice
Also called Immersive Virtual Reality, Guided imagery therapy
The intervention consists of immersive virtual reality-guided imagery delivered using a commercially available VR headset and pre-designed guided imagery software. Participants will wear the VR headset during chemotherapy sessions, which provides access to pre-recorded guided imagery programs.
These programs include standardized audiovisual content such as calming natural scenes, relaxation instructions, and breathing guidance designed to promote relaxation and distraction from pain, anxiety, and fatigue. The content is not developed by the researcher but is selected from existing validated or commercially available VR applications.
Each session will be administered under supervision during chemotherapy and in addition to routine hospital care. The intervention aims to reduce symptom burden by shifting the patient's attention away from treatment-related discomfort through immersive guided imagery experiences.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Guided Imagery plus Routine Care | Experimental | Participants in this group will receive guided virtual reality mindfulness sessions, in addition to their routine chemotherapy care. This intervention is a non-pharmaceutical supportive approach designed to reduce pain, anxiety, and fatigue through immersive guided mindfulness and relaxation during chemotherapy cycles. Receives: Device: Virtual Reality-Guided Imagery |
| Routine Care Only | No intervention | Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 scale where higher scores indicate greater pain severity. The assessment will be conducted at baseline and after the intervention period to evaluate changes in pain levels between the intervention and control groups.
Measured: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Secondary outcomes (2)
Anxiety level
Anxiety levels will be assessed using the Arabic version of the Generalized Anxiety Disorder-7 (GAD-7) scale, a validated 7-item instrument with scores ranging from 0 to 21, where higher scores indicate greater anxiety severity.
Measured: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Fatigue level
Fatigue levels will be measured using the Arabic version of the Brief Fatigue Inventory (BFI-A), which assesses fatigue severity and its impact on daily functioning on a 0-10 scale. Both outcomes will be measured at baseline and after the intervention period to evaluate changes between the intervention and control groups.
Measured: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- This study uses a parallel-group randomized controlled trial design. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive virtual reality-guided imagery in addition to routine care, while the control group will receive routine care only. Both groups will be followed concurrently during the study period, and outcomes will be assessed at baseline and post-intervention to compare changes between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thoalfokar Mohammed Al-Obaidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thoalfokar Mohammed Al-Obaidi, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677436
- Sponsor's protocol ID
- VRGI-PhD-2026
- Acronym
- VRGI-Chemo Tri
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. The study data will be used solely for the purposes of this research and related academic publications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07677436
- Acronym / sponsor ID
- VRGI-Chemo Tri / VRGI-PhD-2026
- Conditions
- Virtual Reality, Guided Imagery, Breast Cancer, Chemotherapy, Pain, Anxiety
- Keywords
- Virtual Reality, Guided Imagery , Breast Cancer, Chemotherapy , Pain, Anxiety , Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Thoalfokar Mohammed Al-ObaidiUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Jun 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.
This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care
Detailed description
This study is a randomized controlled trial with a parallel-group design conducted to evaluate the effect of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing chemotherapy at the National Hospital for Oncology and Hematology in Najaf Governorate, Iraq.
Eligible participants will be randomly allocated into two groups in a 1:1 ratio using block randomization with a fixed block size of four. The experimental group will receive virtual reality-guided imagery in addition to routine hospital care, while the control group will receive routine care only.
The intervention will be delivered during chemotherapy sessions over the study period. The content of the virtual reality-guided imagery will be designed to promote relaxation and psychological comfort, aiming to reduce symptom burden during chemotherapy administration.
Primary and secondary outcomes will be assessed using validated instruments. Pain intensity will be measured using the Numerical Rating Scale (NRS). Anxiety levels will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, and fatigue will be measured using the Brief Fatigue Inventory (BFI). Assessments will be conducted at baseline and after the intervention period.
Data will be analyzed by comparing changes in outcomes between the intervention and control groups to determine the effectiveness of virtual reality-guided imagery in improving symptom management among cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group randomized controlled trial design. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive virtual reality-guided imagery in addition to routine care, while the control group will receive routine care only. Both groups will be followed concurrently during the study period, and outcomes will be assessed at baseline and post-intervention to compare changes between groups.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Guided Imagery plus Routine Care | Experimental | Device: Virtual Reality-Guided ImageryParticipants in this group will receive guided virtual reality mindfulness sessions, in addition to their routine chemotherapy care. This intervention is a non-pharmaceutical supportive approach designed to reduce pain, anxiety, and fatigue through immersive guided mindfulness and relaxation during chemotherapy cycles. |
| Routine Care Only | No intervention | –Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged 18 years or older.
- Histologically confirmed breast cancer.
- Stage I, II, or III breast cancer.
- Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).
- Able to read, write, and communicate.
Key exclusion criteria (5 listed)
- Visual or hearing impairment that prevents the use of virtual reality.
- Serious neurological or psychiatric disorders.
- Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.
- Previous experience with virtual reality-guided imagery.
- Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.
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 |
|---|---|---|
| Virtual Reality-Guided ImageryAlso: Immersive Virtual Reality, Guided imagery therapyThe intervention consists of immersive virtual reality-guided imagery delivered using a commercially available VR headset and pre-designed guided imagery software. Participants will wear the VR headset during chemotherapy sessions, which provides access to pre-recorded guided imagery programs. These programs include standardized audiovisual content such as calming natural scenes, relaxation instructions, and breathing guidance designed to promote relaxation and distraction from pain, anxiety, and fatigue. The content is not developed by the researcher but is selected from existing validated or commercially available VR applications. Each session will be administered under supervision during chemotherapy and in addition to routine hospital care. The intervention aims to reduce symptom burden by shifting the patient's attention away from treatment-related discomfort through immersive guided imagery experiences. | Device | Virtual Reality-Guided Imagery plus Routine Care |
Primary outcome
Pain intensity
Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 scale where higher scores indicate greater pain severity. The assessment will be conducted at baseline and after the intervention period to evaluate changes in pain levels between the intervention and control groups.
2 secondary outcomes
Anxiety level
Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Fatigue level
Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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 30 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. The study data will be used solely for the purposes of this research and related academic publications.
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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.
thulfiqar mohammed abdalhussien, PhD candidate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Guided Imagery in people with Virtual Reality and Guided Imagery, run by Thoalfokar Mohammed Al-Obaidi at 1 site in Iraq.
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 7 inclusion and 5 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 30 Jun 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 Iraq. 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 thulfiqar mohammed abdalhussien, PhD candidate (07831476489, thulfiqar.abd2402p@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)). 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 30 Jun 2026.