Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms
NCT ID: NCT05793957
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2023-04-20
2023-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.
SECONDARY OBJECTIVES:
I. To evaluate whether there is a short-term effect of VR use in anxiety levels.
II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.
EXPLORATORY OBJECTIVE:
I. To assess participants' reported adverse effects associated with VR headset use.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients use VR during chemotherapy infusion on study.
GROUP 2: Patients use smartphone during chemotherapy infusion on study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (VR)
Patients use VR during chemotherapy infusion on study.
Questionnaire Administration
Ancillary studies
Virtual Technology Intervention
Use VR headset
Group 2 (Smartphone)
Patients use smartphone during chemotherapy infusion on study.
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Use smartphone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Use smartphone
Virtual Technology Intervention
Use VR headset
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
* Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health \& Science University (OHSU) South Waterfront Center for Health \& Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
* Chemotherapy treatment lasting at least 10 minutes.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
* Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
* History of seizure or epilepsy.
* History of vertigo or persistent dizziness.
* Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
* Children.
* Pregnant women.
* Decisionally impaired adults.
* Prisoners.
18 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oregon Health and Science University
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ryan Li, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ryan J Li
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-01954
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00025461
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00025461
Identifier Type: -
Identifier Source: org_study_id