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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Pain intensity [Срок оценки: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)]

Вторичные конечные точки (2)

• Anxiety level [Срок оценки: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)]
• Fatigue level [Срок оценки: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Ирак · 1 центр

• National Hospital for Oncology and Hematology in Najaf Governorate — Najaf

Идентификаторы

NCT: NCT07677436 · VRGI-PhD-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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