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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Therapy | Experimental | Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension. |
|
| Control Group | Active Comparator | This group will not watch videos, but will continue with their normal routine as if nothing has changed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality therapy | Behavioral | Participants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Cody Stansel, MSN | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2021 | Nov 8, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Questionnaires | Behavioral | Questionnaires will be completed regarding stress, pain and affect |
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| Measure heart rate | Procedure | To be measured prior to starting treatment and halfway through the 11 minute Video |
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| Cyber sickness measurement | Behavioral | To be measured using the fast motion sickness scale |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |