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Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy (VRGI-Chemo Tri)

27. juni 2026 opdateret af: Thoalfokar Mohammed Al-Obaidi

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

108

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Irak
    • Najaf Governorate
      • Najaf, Najaf Governorate, Irak
        • National Hospital for Oncology and Hematology in Najaf Governorate
        • Kontakt:
        • Ledende efterforsker:
          • Thoalfokar Mohammed Al-Obaidi, PhD candidate

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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, 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.

Andre navne:
  • Fordybende Virtual Reality
  • Guided imagery therapy
Ingen indgriben: Routine Care Only
Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity
Tidsramme: 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.
Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety level
Tidsramme: 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.
Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)
Fatigue level
Tidsramme: 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.
Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Thoalfokar Mohammed Al-Obaidi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

20. juni 2026

Først indsendt, der opfyldte QC-kriterier

27. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VRGI-PhD-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. The study data will be used solely for the purposes of this research and related academic publications.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Smerte

Kliniske forsøg med Virtual Reality-Guided Imagery

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