An interventional study of Virtual Reality-Guided Imagery in Virtual Reality, Guided Imagery and Breast Cancer, sponsored by Thoalfokar Mohammed Al-Obaidi. Not yet recruiting at 1 site in Iraq. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Thoalfokar Mohammed Al-Obaidi · Not applicable, Interventional, and Supportive care
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
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 108 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Thoalfokar Mohammed Al-Obaidi as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Virtual Reality-Guided Imagery
Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention.
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.
Also known as: Immersive Virtual Reality, Guided imagery therapy
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.
Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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.
Time frame: 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.
Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Oct 2026, 3 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 3 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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