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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06199050
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Maastricht Radiation Oncology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Cheryl RoumenMaria Jacobs
Principal Investigator Affiliation	Maastricht UniversityMaastro
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fear, Anxiety, Breast Cancer, Lung Cancer, Prostate Cancer, Head and Neck Cancer, Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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

Experimental: 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

Interventions

Other: - 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.

Other: - Questionnaire: HADS

Hospital Anxiety and Depression Scale, 14 questions likert scale

Other: - Questionnaire: QSC-R23

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

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

Other: - Clinical data collected

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

Contact a Trial Team

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International Sites

Maastricht Radiation Oncology, Maastricht, Netherlands

Status

Recruiting

Address

Maastricht Radiation Oncology

Maastricht, ,

Site Contact

Chiara Coleman

chiara.coleman@maastro.nl

+31 88 44 55 707

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