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Completed

NCT Number: NCT05135260

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.

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Key information

Conditions

Cancer Chemotherapy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality therapy

Behavioral

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

Behavioral

Questionnaires will be completed regarding stress, pain and affect

Measure heart rate

Procedure

To be measured prior to starting treatment and halfway through the 11 minute Video

Cyber sickness measurement

Behavioral

To be measured using the fast motion sickness scale

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Cody Stansel

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2021
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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