CancerNCT05135260
Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
A study testing Virtual reality therapy, Questionnaires and Measure heart rate in people with Cancer and Chemotherapy, run by Cody Stansel at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy
- What is being tested?
- Virtual reality therapy, Questionnaires and Measure heart rate
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 16 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Does not use a device to regulate heart rate or rhythm (such as a pacemaker)
- Not taking antiarrhythmic medications
- Not actively receiving radiopharmaceutical therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: The Effects of 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.
Read the 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
- Conditions
- Cancer, Chemotherapy
- Being tested
- Virtual reality therapy, Questionnaires, Measure heart rate, Cyber sickness measurement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality therapyBehavioural
Participants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes.
QuestionnairesBehavioural
Questionnaires will be completed regarding stress, pain and affect
Measure heart rateProcedure or surgery
To be measured prior to starting treatment and halfway through the 11 minute Video
Cyber sickness measurementBehavioural
To be measured using the fast motion sickness scale
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy | Experimental | Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension. Receives: Behavioral: Virtual reality therapy; Behavioral: Questionnaires; Procedure: Measure heart rate; Behavioral: Cyber sickness measurement |
| Control Group | Active comparator | This group will not watch videos, but will continue with their normal routine as if nothing has changed. Receives: Behavioral: Questionnaires; Procedure: Measure heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 12 months
Measure the affect of Virtual Reality Therapy on improving stress
Measured by stress level using the stress numerical rating
Measured: Approximately 12 months
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)
Measured: Approximately 12 months
Secondary outcomes (1)
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).
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Nov 2021
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cody Stansel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cody Stansel, Vanderbilt-Ingram Cancer Center
- Investigators
- Cody Stansel, MSN, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135260
- Sponsor's protocol ID
- VICC SUPP 2079
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2021
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
- ClinicalTrials.gov ID
- NCT05135260
- Acronym / sponsor ID
- VICC SUPP 2079
- Conditions
- Cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cody StanselUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy | Experimental | Behavioral: Virtual reality therapy, Behavioral: Questionnaires, Procedure: Measure heart rate, Behavioral: Cyber sickness measurementParticipants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension. |
| Control Group | Active comparator | Behavioral: Questionnaires, Procedure: Measure heart rateThis group will not watch videos, but will continue with their normal routine as if nothing has changed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality therapyParticipants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes. | Behavioural | Virtual Reality Therapy |
| QuestionnairesQuestionnaires will be completed regarding stress, pain and affect | Behavioural | Control Group, Virtual Reality Therapy |
| Measure heart rateTo be measured prior to starting treatment and halfway through the 11 minute Video | Procedure or surgery | Control Group, Virtual Reality Therapy |
| Cyber sickness measurementTo be measured using the fast motion sickness scale | Behavioural | Virtual Reality Therapy |
Primary outcome
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.
Measure the affect of Virtual Reality Therapy on improving stress
Time frame: Approximately 12 months
Measured by stress level using the stress numerical rating
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)
1 secondary outcome
Rate of cyber sickness (Virtual Reality Therapy Arm Only)
Time frame: Approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cody Stansel, MSN principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality therapy, Questionnaires and Measure heart rate in people with Cancer and Chemotherapy, run by Cody Stansel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy (time frame: Approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.