Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy (VRGI-Chemo Tri)
Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: thulfiqar mohammed abdalhussien, PhD candidate
- Telefonní číslo: 07831476489
- E-mail: thulfiqar.abd2402p@conursing.uobaghdad.edu.iq
Studijní místa
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Najaf Governorate
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Najaf, Najaf Governorate, Irák
- National Hospital for Oncology and Hematology in Najaf Governorate
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Kontakt:
- thoalfokar mohammed abdalhussien, PhD candidate
- Telefonní číslo: 07831476489
- E-mail: thulfiqar.abd2402p@conursing.uobaghdad.edu.iq
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Vrchní vyšetřovatel:
- Thoalfokar Mohammed Al-Obaidi, PhD candidate
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Virtual Reality-Guided Imagery plus Routine Care
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.
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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.
Ostatní jména:
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Žádný zásah: Routine Care Only
Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pain intensity
Časové okno: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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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.
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Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Anxiety level
Časové okno: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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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.
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Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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Fatigue level
Časové okno: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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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.
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Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- VRGI-PhD-2026
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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