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

Not Applicable

Completed

• Conditions: Chemotherapy; Cancer
• Interventions: Behavioral: Questionnaires; Behavioral: Virtual reality therapy; Procedure: Measure heart rate; Behavioral: Cyber sickness measurement

• Registration Number: NCT05135260
• Lead Sponsor: Cody Stansel

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-26
• Primary Completion: 2023-12-16
• Study Completion: 2023-12-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Therapy	Measure heart rate	Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension.
Control Group	Questionnaires	This group will not watch videos, but will continue with their normal routine as if nothing has changed.
Virtual Reality Therapy	Cyber sickness measurement	Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension.
Control Group	Measure heart rate	This group will not watch videos, but will continue with their normal routine as if nothing has changed.
Virtual Reality Therapy	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.
Virtual Reality Therapy	Questionnaires	Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension.

Primary Outcome Measures

Name	Time	Method
Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy	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	Approximately 12 months	Measured by stress level using the stress numerical rating
Measure the affect of Virtual Reality Therapy on improving pain	Approximately 12 months	Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States