Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThoalfokar Mohammed Al-Obaidi

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality-Guided Imagery

    Device

    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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Virtual Reality-Guided Imagery plus Routine CareExperimental treatment 1 intervention
Group B: Routine Care OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

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Thoalfokar Mohammed Al-Obaidi

Lead sponsor

University of Baghdad

Sponsor institution

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