Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Virtual reality headset

Philippe MENEI, MDPHD

Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

Brain Awake Surgery Using Virtual Reality Headset

Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance

University Hospital, Angers

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application.

* The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room.
* The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)

Use of a virtual reality headset

Vianney BASTIT, MD

Emmanuel BABIN, Prof

Nicolas BON-MARDION, MD

Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy

Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.

The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.

Anxiety score \[minimum value 0 , up to maximum value (worse) 20\] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS)

Score on the VAS pain scale \[minimum value 0, up to maximum value (worse) 10\]

score of EVAN-G questionnaire \[minimum value 0, up to maximum value (worse) 100\]

variation of amount of anti-anxiety medication

Centre Francois Baclesse

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Herbal and Botanical

All Drugs and Chemicals

Peppermint

English Lavender

The VR device used is the Flowly biofeedback virtual headset. This device uses calming immersive virtual worlds along with breathing exercises and a heart rate monitor to guide patients through meditated breathing exercises. The Flowly app is based on a smartphone which will be purchased through the department and used by all participants. The account used is a generic account for our department. No patient information or individualized accounts will be needed. No patient information or data will be collected.

The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.

This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.

Participant will undergo transperineal prostate biopsy as standard of care.

The interventions are for supportive care ONLY.

Virtual Reality Headset

Aromatherapy Patch

Participant will undergo a transperineal prostate biopsy.

Standard of Care

Divya Natesan

Divya Natesan, BS

John Myrga, MD

Bruce Jacobs, MD

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

This is a single-center, randomized controlled trial comparing the use of a virtual reality (VR) device vs. an aromatherapy patch vs. VR+aromatherapy vs. standard of care as a non-anesthetic pain management tool during a transperineal prostate biopsy (TPBx).

208 patients who express interest in participating in the trial will be consented via Redcap. Patients will be centrally, dynamically randomized in a 1:1:1:1 ratio to one of the treatment groups or control group. There will be no subgroup stratification. The randomization will be predetermined by participant ID number. There will be a sealed envelope prepared and labeled with the participant ID that will contain the information for which treatment group a participant is assigned to. Once a participant is consented and assigned an ID, the envelope will be reopened to reveal which intervention the patient will be assigned to.

All participants will take a survey immediately following the procedure and that will conclude their participation in the study.

Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy

This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.

Track number of patients approached and number of patients who sign consent.

Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion.

University of Pittsburgh

Assistant Professor, University of Pittsburgh School of Medicine

Symptoms and General Pathology

Chronic Pain

Cancer Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Participants will be randomly assigned to the intervention group (50 in total).The VR intervention will be identical for each participant and consist of a PC running the immersive virtual reality application with a Virtual Reality headset 110 degrees field of view head mounted display. The VR will be a set of commercial exploratory virtual environment games designed for the HTC Vive headset. The intervention will be used for one month to enable customization to the therapy and record data over a long enough period of time to account for individual short- term changes in pain experience. Participants will be asked to use the VR therapy every day with a time exposure of 30 minutes for four consecutive weeks. There will be one rest day a week (normally a Sunday) where no therapy is given.

The control group will be exposed to 2D PC equivalent versions of the same multimedia experiences but on their PC screen (without the Virtual Reality headset use). These will be functionally similar to the VR experiences.

The following VR experiences will be used:

Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/

The control group will be exposed to 2D equivalent versions of the same multimedia experiences but on their PC screen (without the VR headset use). These will be functionally similar to the VR experiences. These will include:

Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/

2D PC

Crystal Sun, MPH

Bernard M Garrett, Ph.D.

Diane Gromala, Ph.D.

Bernard Garrett, Ph.D.

Bernard M Garett, Ph.D.

Phillipa Hawley

This study seeks to explore the efficacy of immersive multimedia experiences as a practical adjunctive therapeutic intervention in the self-management of the chronic pain associated with cancer patients. A comparative controlled interventional trial and qualitative interpretative-descriptive exploration will be undertaken with 100 cancer patients who are experiencing chronic pain. Participants will be randomly assigned to either a virtual reality (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).

They will undertake either a series of VR interventions, or 2D computer based multimedia control sessions in their own homes over a period of a month. The intervention will be used daily for a month to enable customization to the therapy and record data over a long enough period of time to account for any individual short-term changes in pain.

The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore interactive immersive environments. The control group will be exposed to similar 2D computer based multimedia experiences (without a VR headset) that on home computers. Pre, during, and post pain test scores and quality of sleep assessments will be recorded using standardized tools.

In addition to the primary study, a sub-study will be conducted where ten of the subjects who demonstrated the most improvement in their pain using the VR experience will be selected and invited to explore for any measurable changes in neurological activity using pre and post exposure electroencephalography (EEG).

This study seeks to explore the efficacy of an immersive multimedia experience as a practical therapeutic intervention in the self-management of the chronic pain associated with cancer patients.

This work will inform further clinical studies and future research into the potential uses of immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help identify optimal immersive multimedia environments for use in chronic pain applications, practical determinants for implementation of immersive multimedia for wider practice, and will provide a better theoretical understanding of the mechanisms whereby immersive multimedia works in chronic pain.

JUSTIFICATION

Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years. Due to developments and greater outcomes associated with cancer therapy and management, the number of individuals who survive cancer has risen considerably over the past decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years post cancer diagnosis. However, for some, survivorship is associated with debilitating chronic pain which impacts negatively on quality of life. Reviews have suggested that up to 40% of individuals have survived cancer remain with cancer related chronic pain.

With rapidly emerging immersive multimedia technologies and clinical work in this field, it would appear that immersive multimedia may have significant potential for use as an adjunctive therapeutic measure for pain control. However, there has been little work done to establish the potential use of immersive multimedia in the management of chronic cancer pain to date, as most work on immersive multimedia for pain management has focused on acute pain via distraction. Several researchers have recommended the investigation of immersive multimedia for chronic, long term pain, and the research team completed a pilot study in 2015 to establish best methods and approaches for using immersive multimedia in chronic pain conditions.

OBJECTIVES

To determine if immersive multimedia therapy is effective as an adjunctive intervention in the management of chronic pain in cancer patients?

1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients?
2. How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients?
3. Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients?
4. Do any identifiable neurological changes occur on EEG pre and post immersive multimedia exposure?

RESEARCH METHODS

A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic pain in cancer patients is proposed which will consist of a comparative controlled interventional trial and qualitative interpretative-descriptive exploration.

1. Interventional Trial (Quantitative):

   Participants will be randomly assigned to either a VR therapy group or the control group (50 subjects in each). They will undertake either a series of immersive VR interventions, or control sessions (using 2D multimedia on personal computers) in their own homes over a period of a month.

   To ensure the multi-dimensional aspects of chronic pain experienced by individuals are measured adequately, pain assessment tools have been selected that will address different aspects of each participant's' chronic pain and functional capacity. To measure the impact of VR on each participant's pain intensity, the Visual Analog Scale will be used during the VR and control experiences, pre and post exposure and at 10 minute intervals. In order to measure the change in pain during the therapy experience, and overall sleep quality, at the end of each week, participants will also be asked to complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality Immersion Tool (to assess how immersive they found the experience that week).
2. Interpretive Description Study (Qualitative):

A Qualitative Interpretative-Descriptive exploration will be undertaken alongside the trial to allow for a more open exploration of participants experiences and to further understanding of the perceptions associated with the use of immersive multimedia and any impact upon their chronic pain. An interpretative description (ID) approach will be used for this aspect of the study. This methodology allows for an inductive descriptive analysis of the phenomena, and was chosen as it is ideal for small scale studies, allowing for generation of themes, patterns and theory associated with the patient's experience.

Following the completion of the clinical trial all participants will be sent an exploratory questionnaire to discover their perceptions of immersive multimedia and its value (if any) in the control of their chronic pain. In this questionnaire they will also be invited to participate in one of two focus group interviews. Data from this will be analyzed and used to support purposeful sampling of individuals to take part in the following focus-group interviews, to include those subjects with a range of diverse opinions and ideas. As themes and categories emerge from the data the researchers will seek to adapt the focus-group interview sample with the purpose of strengthening the emerging theory and patterns by including individuals who will help further define the characteristics of these themes and categories.

Data Analysis

Quantitative Data: Descriptive and inferential statistical analysis will be performed on the pain scores. For face-value quantitative indicators of potential effects univariate descriptive statistics will be employed. Data will be analyzed for central tendency, dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS statistical analysis software to establish distribution and variance. Likewise, quantitative data from the questionnaires will be analysed in this fashion. Data will be explored for differences in the pain scales for the VR group and the control group at each time point to analyze for any indications of changes immediately following the experience using Linear Mixed Effects Modelling using SPSS software.

Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data analysis software and read, re-read and coded for thematic elements by the PIs.

Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients

A questionnaire as well as a focus group interview will be conducted one month after participants' VR session. Questions will focus on their experience of using VR (i.e., positives for using VR, negatives for using VR, would they use this therapy or not in the future etc.)

A questionnaire will be conducted for each environment the participant uses during the 4-week interval. Questions will focus on the whether the participant found the environment to be immersive, whether they felt 'present' in the experience, and additional comments on the sound, visual, and overall feelings about the environment used of the week.

Use of the visual analog score for pain experience. Subjects will be asked about their pain intensity prior to the start of the VR session and asked for their pain intensity right after each VR session (recall for during the VR session and post VR session)

Observe change in neuronal activity in the brain before and after a 30min VR session using EEG.

The McGill Pain Questionnaire is used to monitor the pain over time for participants in the study for any significant changes in pain during the intervention over the 4 weeks interval.

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over the 4 weeks interval.

The SF-12 is used to assess the impact of health on an individual's everyday life over the 4 weeks interval.

Lotte & John Hecht Memorial Foundation

Simon Fraser University

Fraser Health

University of British Columbia

Associate Professor

Patients randomized in this arm will have the virtual reality headset associated to the standard care

patients randomized in this arm will have standard care.

Each patient in this treatment group will use a virtual reality headset during 3 procedures. During each procedure, the pain level will be assessed and compared with the assessed group.

Yves REGUERRE

Emilie TECHER

Yves REGUERRE, MD

DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.

intervention plus standard care versus standard care

Use of Virtual Reality in Pain Management in Pediatric Oncology

Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial

Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))

Centre Hospitalier Universitaire de la Réunion

Behaviors and Mental Disorders

Anxiety Disorders

Central Nervous System Depressants

Anesthetics

In addition to local standard anaesthesia, patients benefit from a virtual reality session during the operation using a virtual reality headset

Patients benefit only from a local anaesthesia is provided according to the standard procedure

Once the patient is on the operating table, the nurse proposes the different possible VR scenarios and installs the RV headset and an audio headset.

Audrey BECMEUR, Nurse

Emilie DEBEAUPUIS

VIRGINIE JAOUL, MD

Samia TESTA, MD

Virtual Reality (VR) is an interactive and immersive technology that allows you to evolve in a three-dimensional environment created by computer. It appeals to the senses of people by reproducing universes close to reality or imaginary. This process is currently the subject of numerous studies in the field of health because it is a non-invasive tool, a non-pharmacological alternative for the management of pain, anxiety and patient satisfaction.

People with cancer can have a complex care pathway with psychological, anxiety-provoking and potentially painful repercussions. It is for these reasons that offering VR in the operating room for certain procedures under local anesthesia would improve the experience and comfort of care.

BOREV study will assess the interest of VR on pain for procedures under local anesthesia in the operating room in the context of cancer care. The software used, called HypnoVR©, is a medical device, developed specifically for the management of anxiety and pain through hypnosis, sophrology and relaxation techniques.

The main objective of this study is to compare the maximum pain felt with and without RV for different oncological surgical procedures performed under local anesthesia including anesthetic procedures and surgical procedures. The secondary objectives that will support this research are: the evaluation of the level of anxiety, the link with the pain component via the Analgesia Nociception Index (ANI), as well as the satisfaction of the patient and the operator.

According to the results obtained, the VR device could lead to a change in practice in the management of patients and thus be offered on a larger scale within the framework of the management of pain and anxiety

Description of the modalities for recruiting :

During the preoperative consultation, the surgeon or anesthesiologist presents the study to the patient with a cancer requiring a surgery under local anesthesia. He gives the patient the consent form to participate in the study.

Once the consent form has been signed by the patient and the investigator, the investigator prescribes a screening test before surgery.

Patients registration and randomization :

Any patient who has signed an informed consent form (ICF) must be registered in the eCRF in order to be assigned a patient number.

Randomization will be centralized and performed via the eCRF. Patients will be randomly assigned (1:1) at the latest on the day of the surgery.

Experimental group : Local anaesthesia + virtual reality versus Control group : Anesthesia only.

Surgery period :

Regardless of the group, all patients :

* Will receive local anaesthesia according to the standard procedure required for the operation
* Hemodynamic parameters will be measured
* Will be questioned before, immediately after, and at a distance from the surgical procedure on their state of anxiety and immediately after the surgical procedure on the maximum pain felt during the procedure,
* Will be questioned on their satisfaction at the end of surgery.

ANI will be measured before, during and after the operation in patients included at the Saint Herblain site.

A virtual reality headset will be positioned on the patient before the start of the surgical procedure.

Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room

Maximum subjective pain is measured by a numerical pain scale of 0 to 10. (0 : no pain ; 10 : maximum pain)

Pain is evaluated in continuous by to the Analgesia Nociception Index (ANI) measured from the PhysioDoloris monitor (MDMS).

It is a unitless index between 0 and 100, which describes:

Pain: 0 ≤ ANI ≤ 40 Discomfort/anxiety: 40 \< ANI ≤ 65 Comfort/well-being: 65 \< ANI ≤ 100

Heart rate, blood pressure and respiratory rate measured by a multiparametric monitor type M540

Anxiety is measured by a visual analogue scale of 0 to 10. (0 : no anxiety ; 10 : maximum anxiety)

Satisfaction is evaluated by a Lickert scale (Absolutely satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Absolutely dissatisfied)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brain Awake Surgery Using Virtual Reality Headset	NCT03010943	Brain Tumor Virtual Reality	Virtual reality...	18 Years -	University Hospital, Angers
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy	NCT04481893	Thyroid Cancer Thyroidectomy	Use of a virtua...	18 Years -	Centre Francois Baclesse
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy	NCT06296147	Prostate Cancer	Virtual Reality... Aromatherapy Pa... Standard of Car...	18 Years -	University of Pittsburgh
Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients	NCT02995434	Chronic Pain Cancer	Virtual Reality... 2D PC	16 Years -	University of British Columbia
Use of Virtual Reality in Pain Management in Pediatric Oncology	NCT05592132	Pediatric Tumor	Virtual reality...	6 Years - 18 Years	Centre Hospitalier Universitaire de la Réunion
Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room	NCT05287854	Cancer	Virtual reality...	18 Years -	Institut Cancerologie de l'Ouest
Brain Awake Surgery Using Virtual Reality Headset	NCT03010943	Brain Tumor Virtual Reality	Virtual reality...	18 Years -	University Hospital, Angers

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