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Clinical Trials/NCT05135260
NCT05135260
Completed
Not Applicable

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

Cody Stansel1 site in 1 country99 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Cody Stansel
Enrollment
99
Locations
1
Primary Endpoint
Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy
Status
Completed
Last Updated
last year

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

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 16, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cody Stansel
Responsible Party
Sponsor Investigator
Principal Investigator

Cody Stansel

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

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
  • 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.

Exclusion Criteria

  • Not provided

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)

Study Sites (1)

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