The Effect of 360° Virtual Reality Movies on Fear and Anxiety

NCT06199050 | Completed

• 1 other identifier: ENGAGE
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

Conditions

Fear; Anxiety; Breast Cancer; Lung Cancer; Prostate Cancer; Head and Neck Cancer; Brain Tumor

Outcome Measures

Primary Outcomes (6)

• Subjective fear, anxiety and stress (QSC-R23)

  What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Questionnaire on Stress in Cancer Patients revised version (QSC-R23). Dutch version of the Questionnaire on stress symptoms (QSC-R23) - 23 questions likert scale.

  1 month

• Subjective fear, anxiety and stress (PROMS)

  What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Patient Reported Outcome Measures (PROMS) questionnaires. Patient reported outcome measures.

  1 month

• Subjective fear, anxiety and stress (HADS)

  What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Hospital Anxiety and Depression Scale (HADS). Hospital Anxiety and Depression Scale (HADS) - 14 questions likert scale

  1 month

• Subjective fear, anxiety and stress (SPIRIT)

  What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the additional treatment-specific questions (SPIRIT). SPecifIc RadIation Treatment related questions (SPIRIT) - 10 questions likert scale

  1 month

• Relationship with demographics

  Is there a relationship between fear, anxiety, stress experience, and the demographics of a patient.(I.e., prognosis, cancer indication, kind of treatment procedure)

  1 month

• Relationship between fear, anxiety, stress experience, and answers given in the standard PROMS questionnaire

  Is there a relationship between fear, anxiety, stress experience, and answers given to specific questions in the standard PROMS questionnaire. (e.g., the general quality of life questionnaire (EQ5D), especially on FEAR and DEPRESSION and health-related quality of life (SF-36)?)

  1 month

Study Arms (2)

360° Virtual Reality Movies

EXPERIMENTAL

assess the amount of fear, anxiety and stress by using specific questionnaires: * SPecifIc RadIation Treatment related questions (SPIRIT) * Hospital Anxiety and Depression Scale (HADS) * Dutch version of the Questionnaire on stress symptoms (QSC-R23) General questions: * Education level * Marietal status * Medication use (in order to assess influence on fear) * Previous cancer diagnosis * Acquired information on treatment * Expected fear and anxiety mitigation strategies * Other cancer treatments (e.g. chemotherapy no, prior to RT, during RT, or after RT; surgery prior to or after RT) * PROM at baseline Clinical data: * Age * Gender * Cancer type * WHO status * TNM

Other: Questionnaire: SPIRIT; Other: Questionnaire: HADS; Other: Questionnaire: QSC-R23; Other: General questions; Other: Clinical data collected

Group without intervention

EXPERIMENTAL

In a measurement over 5 months without any intervention the investigators have assessed the amount of fear, anxiety and stress by using a specific subjective questionnaire on the items below: assess the amount of fear, anxiety and stress by using specific questionnaires: * SPecifIc RadIation Treatment related questions (SPIRIT) * Hospital Anxiety and Depression Scale (HADS) * Dutch version of the Questionnaire on stress symptoms (QSC-R23) General questions: * Education level * Marietal status * Medication use (in order to assess influence on fear) * Previous cancer diagnosis * Acquired information on treatment * Expected fear and anxiety mitigation strategies * Other cancer treatments (e.g. chemotherapy no, prior to RT, during RT, or after RT; surgery prior to or after RT) * PROM at baseline Clinical data: * Age * Gender * Cancer type * WHO status * TNM

Other: Questionnaire: SPIRIT; Other: Questionnaire: HADS; Other: Questionnaire: QSC-R23; Other: General questions; Other: Clinical data collected

Interventions

Questionnaire: SPIRIT OTHER

T0: Before the first intake at Maastro, the Trialpoli (TP) contacts a patient via phone to inform whether or not he is interested in participating in this study. If the patient shows interest in participating in the study, he will be invited for a consultation with the Trialpoli. This consultation takes place on the day of intake at Maastro. After consent, the patient is randomized to fill out T0 before or after the intake. T1: After filling out T0, the patient receives the ENGAGE information card with the url en QR code to the VR-movie. After watching the VR movie and before start RT the patient is asked to fill in T1. This questionnaire is distributed with instructions by the TP. T2: Between the 5th and the 15th radiation treatment, patients will be asked to fill in the questionnaires for the third and last time. The Patient Information Form (PIF) and Informed Consent (IC) are added in a separate document.

360° Virtual Reality Movies; Group without intervention

Questionnaire: HADS OTHER

Hospital Anxiety and Depression Scale, 14 questions likert scale

360° Virtual Reality Movies; Group without intervention

Questionnaire: QSC-R23 OTHER

Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale

360° Virtual Reality Movies; Group without intervention

General questions OTHER

* Education level * Marietal status * Medication use (in order to assess influence on fear) * Previous cancer diagnosis * Acquired information on treatment * Expected fear and anxiety mitigation strategies * Other cancer treatments (e.g. chemotherapy no, prior to RT, during RT, or after RT; surgery prior to or after RT) * PROM at baseline

360° Virtual Reality Movies; Group without intervention

Clinical data collected OTHER

Clinical data in HIX: * Age * Gender * Cancer type * WHO status * TNM

360° Virtual Reality Movies; Group without intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast- (only VMDIP), lung-, prostate-, head and neck cancer, a brain tumor.
• Age 18+
• Being able to speak, read and write in Dutch
• General interview between radiation oncologist and patient (= Intake)
• Ability to give written informed consent before the start of the study
• Decision talk about start of treatment must have taken place

You may not qualify if:

• Patients who are already receiving radiotherapy treatment
• Pre-operative consultation for breast cancer patients
• Patients who have seen the VR-videos already

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Head and Neck Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cheryl Roumen

  Maastricht University

  STUDY DIRECTOR

• Maria Jacobs

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: January 10, 2024
• Study Start: June 16, 2023
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

NL (1)