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Completed

NCT Number: NCT06199050

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

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.

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Key information

Conditions

Fear Anxiety Anxiety Disorders Brain Diseases Brain Neoplasms Brain Tumor Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht Radiation Oncology

Maastricht, Netherlands

About this study

In ENGAGE, a KWF Samenloop Voor Hoop subsidized project, we have developed VR movies to reduce fear and anxiety for patients who are going to be treated at Maastro. These movies are based on where most fear and anxiety are experienced and have been developed after extensive discussion with different disciplines in patient care and with agreement of the Director Patient Care. The movies include: 1) Mouldroom, 2) VMDIBH mamma photons, 3) Head and Neck photons, 4) Lung photons, 5) CT-scan, 6) Prostate photons, and 7) Head and Neck/ Neuro protons. Currently, the web-based 360° movies are implemented in clinical practice and the VR glasses with the 360° movies will be used as soon as social work has decided on where to integrate the use in the care pathway.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Questionnaire: HADS

Other

Hospital Anxiety and Depression Scale, 14 questions likert scale

Questionnaire: QSC-R23

Other

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

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

Clinical data collected

Other

Clinical data in HIX:

  • Age
  • Gender
  • Cancer type
  • WHO status
  • TNM

Primary outcomes

  1. Subjective fear, anxiety and stress (QSC-R23)

    Time frame: 1 month

    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.

  2. Subjective fear, anxiety and stress (PROMS)

    Time frame: 1 month

    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.

  3. Subjective fear, anxiety and stress (HADS)

    Time frame: 1 month

    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

  4. Subjective fear, anxiety and stress (SPIRIT)

    Time frame: 1 month

    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

  5. Relationship with demographics

    Time frame: 1 month

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

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

    Time frame: 1 month

    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)?)

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Acronym: ENGAGE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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