FearENGAGENCT06199050
The Effect of 360° Virtual Reality Movies on Fear and Anxiety
A study testing Questionnaire: SPIRIT, Questionnaire: HADS and Questionnaire: QSC-R23 in people with Fear and Anxiety, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear, Anxiety, Breast Cancer
- What is being tested?
- Questionnaire: SPIRIT, Questionnaire: HADS and Questionnaire: QSC-R23
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jun 2023to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are already receiving radiotherapy treatment
- Pre-operative consultation for breast cancer patients
- Patients who have seen the VR-videos already
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Fear, Anxiety, Breast Cancer, Lung Cancer, Prostate Cancer, Head and Neck Cancer
- Being tested
- Questionnaire: SPIRIT, Questionnaire: HADS, Questionnaire: QSC-R23, General questions, Clinical data collected
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Head and Neck Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire: SPIRITOther
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: HADSOther
Hospital Anxiety and Depression Scale, 14 questions likert scale
Questionnaire: QSC-R23Other
Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale
General questionsOther
- 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 collectedOther
Clinical data in HIX:
- Age
- Gender
- Cancer type
- WHO status
- TNM
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Questionnaire: SPIRIT; Other: Questionnaire: HADS; Other: Questionnaire: QSC-R23; Other: General questions; Other: Clinical data collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)?)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start16 Jun 2023
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Roumen, Study director, Maastricht UniversityMaria Jacobs, Principal investigator, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199050
- Sponsor's protocol ID
- ENGAGE
- Acronym
- ENGAGE
- Status last verified
- Oct 2025
- First submitted
- 16 Jun 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 360° Virtual Reality Movies on Fear and Anxiety
- ClinicalTrials.gov ID
- NCT06199050
- Acronym / sponsor ID
- ENGAGE / ENGAGE
- Conditions
- Fear, Anxiety, Breast Cancer, Lung Cancer, Prostate Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 360° Virtual Reality Movies | Experimental | Other: Questionnaire: SPIRIT, Other: Questionnaire: HADS, Other: Questionnaire: QSC-R23, Other: General questions, Other: Clinical data collectedassess 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 |
| Group without intervention | Experimental | Other: Questionnaire: SPIRIT, Other: Questionnaire: HADS, Other: Questionnaire: QSC-R23, Other: General questions, Other: Clinical data collectedIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who are already receiving radiotherapy treatment
- Pre-operative consultation for breast cancer patients
- Patients who have seen the VR-videos already
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire: SPIRITT0: 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. | Other | 360° Virtual Reality Movies, Group without intervention |
| Questionnaire: HADSHospital Anxiety and Depression Scale, 14 questions likert scale | Other | 360° Virtual Reality Movies, Group without intervention |
| Questionnaire: QSC-R23Dutch version of the Questionnaire on stress symptoms, 23 questions likert scale | Other | 360° Virtual Reality Movies, Group without intervention |
| 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 | Other | 360° Virtual Reality Movies, Group without intervention |
| Clinical data collectedClinical data in HIX: * Age * Gender * Cancer type * WHO status * TNM | Other | 360° Virtual Reality Movies, Group without intervention |
Primary outcome
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.
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.
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
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
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)
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)?)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Roumen study director
Maastricht University
Maria Jacobs principal investigator
Maastro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire: SPIRIT, Questionnaire: HADS and Questionnaire: QSC-R23 in people with Fear and Anxiety, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective fear, anxiety and stress (QSC-R23) (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.