NCT07754864

Brief Summary

Introduction: External Beam Radiotherapy is a common strategy used in the treatment of various cancers, and the patient undergoing treatment using this strategy many times experiences anxiety and stress. While patient education is essential for anxiety management, traditional methods may not adequately address the complex needs of patients in Oman, where no standardized pre-treatment education protocols exist. Virtual Reality (VR) technology offers promising potential for enhancing patient education and reducing anxiety. Purpose/Aim: This study aims to evaluate the effectiveness of VR-based education in reducing anxiety levels, improving treatment experience, and increasing satisfaction among adult patients with cancer receiving external beam radiotherapy (EBRT) in Oman. Research Design: A randomized control trial will be conducted with 122 patients undergoing external beam radiotherapy from SQCCCRC (Sultan Qaboos Comprehensive Cancer Care \& Research Center) and the National Oncology Center (NOC) in Royal Hospital. These patients will be randomly allocated to either the intervention group (VR-based education) or the control group (standard education). The intervention group will view an educational VR video via immersive headsets, while the control group will receive standard care. Study Instruments: Anxiety levels will be measured using the State Anxiety Inventory (SAI), the Radiotherapy Experience Questionnaire (RTEQ) will be used to measure treatment experience, and the Patient Satisfaction Questionnaire (PSQ) will be used to measure patient satisfaction. Plan for Data Analysis: The Statistical Package for Social Sciences (SPSS) version 29 will be used for data analysis. Descriptive statistics in terms of mean, standard deviation, frequencies, and percentages will be used to summarize patient characteristics. Paired t-tests will be used to compare pre- and post-intervention anxiety levels within each group. Independent t-tests will be used to assess differences between the intervention and control groups. Analysis of Covariance (ANCOVA) will be used to control confounding variables such as age, education level, and baseline anxiety scores. Expected Outcomes: The researcher predicts that VR education will lower anxiety levels while delivering better patient experiences and higher satisfaction than traditional education methods. Current study findings will guide patient education protocol development and help to establish standardized pre-radiotherapy education guideline standards in Oman

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

December 22, 2025

Last Update Submit

August 4, 2026

Conditions

Keywords

Virtual RealityEducationAnxietyTreatment ExperiencePatients SatisfactionCancerExternal Beam Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    ▪ Anxiety is measured using the State-Trait Anxiety Inventory (STAI); the scale ranges from a minimum of 20 to a maximum of 80 per subscale, with higher scores indicating a worse outcome for anxiety

    Up to 7 months

Secondary Outcomes (2)

  • Patient Experience

    Up to 7 months

  • ▪ Patient satisfaction

    Up to 7 months

Study Arms (2)

VR-based education group (intervention group)

EXPERIMENTAL

The intervention group will view an educational VR video via immersive headsets

Device: VR-based education

The Control / Comparison group (standard education)

NO INTERVENTION

The control group will receive standard care.

Interventions

an educational VR video via immersive headsets

VR-based education group (intervention group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 years or above
  • Willing to participate
  • Provide informed consent
  • Scheduled for their first external beam radiotherapy treatment

You may not qualify if:

  • Pediatric cancer patients
  • Scheduled for head \& neck external beam radiotherapy
  • Previously underwent radiotherapy treatment
  • Have severe visual or hearing difficulties
  • Require emergency radiotherapy treatment
  • Have a history of psychiatric illness
  • Require ICU admission
  • Experience severe motion sickness or vertigo
  • Unable to tolerate the VR headset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health, Royal Hospital

Muscat, Muḩāfaz̧at Masqaţ, 111, Oman

Location

MeSH Terms

Conditions

NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinding Application: * Participants (single-blind): While the study mentions blinding, it states that the researcher will emphasize to participants the importance of not disclosing their group assignment to healthcare providers, implying participants will know their allocation (intervention or control group) to some extent but are instructed not to reveal it to others involved in their care. * Healthcare Providers/Clinical Staff: Healthcare providers will not be informed about the group allocations of the patients. * Researcher: The researcher will not be involved in delivering standard care to the participants to maintain blinding.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: VR-based education group (The intervention group) will view an educational VR video via immersive headsets
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

August 10, 2026

Study Start

February 9, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

August 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

All IPDs are confidential in this randomized clinical trial.

Locations