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

NCT ID: NCT06199050

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2025-05-13

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.

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; Brain Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

360° Virtual Reality Movies

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

Group Type: EXPERIMENTAL

Questionnaire: SPIRIT

Intervention Type: 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

Intervention Type: OTHER

Hospital Anxiety and Depression Scale, 14 questions likert scale

Questionnaire: QSC-R23

Intervention Type: OTHER

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

General questions

Intervention Type: 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

Intervention Type: OTHER

Clinical data in HIX:

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

Group without intervention

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

Group Type: EXPERIMENTAL

Questionnaire: SPIRIT

Intervention Type: 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

Intervention Type: OTHER

Hospital Anxiety and Depression Scale, 14 questions likert scale

Questionnaire: QSC-R23

Intervention Type: OTHER

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

General questions

Intervention Type: 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

Intervention Type: OTHER

Clinical data in HIX:

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

Interventions

Questionnaire: SPIRIT

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.

Intervention Type: OTHER

Questionnaire: HADS

Hospital Anxiety and Depression Scale, 14 questions likert scale

Intervention Type: OTHER

Questionnaire: QSC-R23

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Clinical data collected

Clinical data in HIX:

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Roumen

Role: STUDY_DIRECTOR

Maastricht University

Maria Jacobs

Role: PRINCIPAL_INVESTIGATOR

Maastro

Locations

Maastricht Radiation Oncology

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

ENGAGE

Identifier Type: -

Identifier Source: org_study_id