Anxiety, Breast Cancer, Chemotherapy, Fatigue, Guided Imagery, Pain, Virtual Reality
Conditions
Keywords
Virtual Reality, Guided Imagery , Breast Cancer, Chemotherapy , Pain, Anxiety , Fatigue
Brief 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. 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.
Interventions
DEVICEVirtual Reality-Guided Imagery
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.
Sponsors
Thoalfokar Mohammed Al-Obaidi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The study is single-blinded. Due to the nature of the intervention, participants will be aware of whether they receive virtual reality-guided imagery or routine care. However, the outcome assessor responsible for collecting and evaluating study data will be blinded to group allocation to minimize assessment bias. This approach is used to ensure objectivity in outcome measurement and improve the internal validity of the study.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level | Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3) | 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. |
| Fatigue level | Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3) | 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. |
Countries
Iraq
Contacts
CONTACTthulfiqar mohammed abdalhussien, PhD candidate
Outcome results
None listed