Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Questionnaire Administration

Telephone-Based Intervention

Virtual Technology Intervention

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English. 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: Social or psychiatric conditions that may interfere with compliance. 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.

Sites / Locations

OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (VR)

Group 2 (Smartphone)

Arm Description

Patients use VR during chemotherapy infusion on study.

Patients use smartphone during chemotherapy infusion on study.

Outcomes

Primary Outcome Measures

Difference in anxiety levels

Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.

Secondary Outcome Measures

Short-term difference in anxiety levels

Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.

Participants' satisfaction with the VR device

Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.

Full Information

NCT ID

NCT05793957

First Posted

March 17, 2023

Last Updated

September 29, 2023

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT05793957

Brief Title

Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

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?

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2023 (Actual)

Primary Completion Date

November 23, 2023 (Anticipated)

Study Completion Date

November 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematopoietic and Lymphoid System Neoplasm, Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm, Malignant Solid Neoplasm, Malignant Thoracic Neoplasm

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (VR)

Arm Type

Experimental

Arm Description

Patients use VR during chemotherapy infusion on study.

Arm Title

Group 2 (Smartphone)

Arm Type

Active Comparator

Arm Description

Patients use smartphone during chemotherapy infusion on study.

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Based Intervention

Intervention Description

Use smartphone

Intervention Type

Other

Intervention Name(s)

Virtual Technology Intervention

Other Intervention Name(s)

Virtual Reality Intervention, Virtual Technology

Intervention Description

Use VR headset

Primary Outcome Measure Information:

Title

Difference in anxiety levels

Description

Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.

Time Frame

Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed

Secondary Outcome Measure Information:

Title

Short-term difference in anxiety levels

Description

Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.

Time Frame

Before VR goggle use and immediately after chemotherapy infusion is complete

Title

Participants' satisfaction with the VR device

Description

Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.

Time Frame

Immediately after chemotherapy infusion is complete

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English. 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: Social or psychiatric conditions that may interfere with compliance. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan J Li

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ryan J. Li

Phone

503-494-5355

Email

lry@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Ryan J. Li

Hematopoietic and Lymphoid System Neoplasm, Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial