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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135260
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Cody Stansel, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cancer Chemotherapy Behavioral: Virtual reality therapy Behavioral: Questionnaires Procedure: Measure heart rate Behavioral: Cyber sickness measurement Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

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




Primary Outcome Measures :
  1. 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.

  2. Measure the affect of Virtual Reality Therapy on improving stress [ Time Frame: Approximately 12 months ]
    Measured by stress level using the stress numerical rating

  3. 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 Outcome Measures :
  1. Rate of cyber sickness (Virtual Reality Therapy Arm Only) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135260


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vumc.org

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service for Timely Access    800-811-8480    cip@vumc.org   
Principal Investigator: Cody Stansel, MSN         
Sub-Investigator: Alexander McLeod, BA         
Sub-Investigator: Shubham Gulati, BE, MS         
Sponsors and Collaborators
Cody Stansel
Investigators
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Principal Investigator: Cody Stansel, MSN Vanderbilt-Ingram Cancer Center
  Study Documents (Full-Text)

Documents provided by Cody Stansel, Vanderbilt-Ingram Cancer Center:
Informed Consent Form  [PDF] August 11, 2021

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Responsible Party: Cody Stansel, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT05135260    
Other Study ID Numbers: VICC SUPP 2079
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No