Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT05793957
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
Detailed Description:
PRIMARY OBJECTIVE:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: