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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Chemotherapy
• Intervention / Treatment: Behavioral: Virtual reality therapy; Behavioral: Questionnaires; Procedure: Measure heart rate; Behavioral: Cyber sickness measurement

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cody Stansel
• Investigators: Principal Investigator: Cody Stansel, MSN, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 16, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VICC SUPP 2079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No