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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05135260
• Other study ID #: VICC SUPP 2079
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cody Stansel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measure the affect of Virtual Reality Therapy on improving stress	Measured by stress level using the stress numerical rating	Approximately 12 months
Primary	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	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