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Clinical Trials/NCT05135260
NCT05135260CompletedNot Applicable

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

Cody Stansel1 site in 1 country99 target enrollmentStarted: November 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
99
Locations
1
Primary Endpoint
Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy

Study Overview

Brief Summary

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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 Criteria

  • •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

Arms & Interventions

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.

Intervention: Virtual reality therapy (Behavioral)

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.

Intervention: Questionnaires (Behavioral)

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.

Intervention: Measure heart rate (Procedure)

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.

Intervention: Cyber sickness measurement (Behavioral)

Control Group

Active Comparator

This group will not watch videos, but will continue with their normal routine as if nothing has changed.

Intervention: Questionnaires (Behavioral)

Control Group

Active Comparator

This group will not watch videos, but will continue with their normal routine as if nothing has changed.

Intervention: Measure heart rate (Procedure)

Outcomes

Primary Outcomes

Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy

Time Frame: Approximately 12 months

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.

Measure the affect of Virtual Reality Therapy on improving stress

Time Frame: Approximately 12 months

Measured by stress level using the stress numerical rating

Measure the affect of Virtual Reality Therapy on improving pain

Time Frame: Approximately 12 months

Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst)

Secondary Outcomes

  • Rate of cyber sickness (Virtual Reality Therapy Arm Only)(Approximately 12 months)

Investigators

Sponsor
Cody Stansel
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Cody Stansel

Principal Investigator

Vanderbilt-Ingram Cancer Center

Study Sites (1)

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