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

Sponsor
Cody Stansel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05135260
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Virtual reality therapy
  • Behavioral: Questionnaires
  • Procedure: Measure heart rate
  • Behavioral: Cyber sickness measurement
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Measure the affect of Virtual Reality Therapy on improving stress [Approximately 12 months]

    Measured by stress level using the stress numerical rating

  3. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Cody Stansel

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Cody Stansel, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT05135260
Other Study ID Numbers:
  • VICC SUPP 2079
First Posted:
Nov 26, 2021
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 22, 2022