Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic

Study Overview
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Brief Summary
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This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

Detailed Description
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Objectives: Primary Objective: - To deploy and evaluate virtual reality as an intervention for stress, pain, and negative affect Secondary Objective: - To evaluate cyber sickness and patient satisfaction related to the virtual reality treatment

Official Title
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The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic

Conditions
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Cancer, Chemotherapy

Intervention / Treatment
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* Behavioral: Virtual reality therapy
* Behavioral: Questionnaires
* Procedure: Measure heart rate
* Behavioral: Cyber sickness measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At or above the age of 18 English Speaking Diagnosed with cancer No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition Not sensitive to motion sickness Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp) Does not use a device to regulate heart rate or rhythm (such as a pacemaker) Not taking antiarrhythmic medications Not actively receiving radiopharmaceutical therapy Exclusion: To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience. Patients who are asleep prior to consenting will not be asked to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Therapy<br>Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension. | Behavioral: Virtual reality therapy<br>* Participants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes.<br>Behavioral: Questionnaires<br>* Questionnaires will be completed regarding stress, pain and affect<br>Procedure: Measure heart rate<br>* To be measured prior to starting treatment and halfway through the 11 minute Video<br>Behavioral: Cyber sickness measurement<br>* To be measured using the fast motion sickness scale<br>|
| Active Comparator: Control Group<br>This group will not watch videos, but will continue with their normal routine as if nothing has changed. | Behavioral: Questionnaires<br>* Questionnaires will be completed regarding stress, pain and affect<br>Procedure: Measure heart rate<br>* To be measured prior to starting treatment and halfway through the 11 minute Video<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy | Measured by the Positive and Negative Affect Scale (0=minimum to 5=maximum). Consisting of a number of words that describe different feelings and emotions. Patients are instructed to indicate to what extent they currently feel each of the feelings or emotions. Afterwards, patient responses are scored to produce a numerical positive affect score and a negative affect score. | Approximately 12 months | 
| Measure the affect of Virtual Reality Therapy on improving stress | Measured by stress level using the stress numerical rating | Approximately 12 months | 
| Measure the affect of Virtual Reality Therapy on improving pain | Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst) | Approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cyber sickness (Virtual Reality Therapy Arm Only) | Measured with the Fast MS Scale (FMS), a verbal rating scale ranging from zero (no sickness at all) to 20 (frank sickness). | Approximately 12 months |