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Not yet recruiting NCT07677436

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

No phase Interventional Virtual Reality Guided Imagery Breast Cancer Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-Guided Imagery.
Who it may be relevant to
Registry conditions: Virtual Reality, Guided Imagery, Breast Cancer, Chemotherapy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

Overview

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

  • Device Virtual 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, a

Primary outcome measures

  • Pain intensity [Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Iraq · 1 center
  • National Hospital for Oncology and Hematology in Najaf Governorate — Najaf

Identifiers

NCT: NCT07677436 · VRGI-PhD-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗